Regulatory Affairs Archives - AdvaMed

Medical Device Submissions Workshops – Premarket Approval (PMA)

Wintana Zerai — Fri, 08 Nov 2024 16:21:33 +0000

Events

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Join AdvaMed for the Medical Device Submissions Workshop: Premarket Approval (PMA) happening February 6-7, 2025! This workshop will connect attendees with seasoned industry experts to breakdown the PMA application process. You’ll gain insights on aligning with FDA expectations, structuring effective submissions, and reducing the risk of delays or rejections—ensuring a smoother path to market for your technologies.

Using real-world case studies, this workshop will walk attendees through the practical steps of filing a PMA and provide actionable insights on how to best navigate the PMA submission process, best practices, common pitfalls, and more! Take advantage of this chance to connect with other medtech professionals to foster partnerships and provide support for future regulatory challenges. Secure your spot for the two-day PMA Workshop!

Who should attend?

These workshops are valuable for anyone aiming to streamline the regulatory process, reduce submission risks, and confidently bring their device to market such as:

Medical device professionals new to the FDA regulatory submission process
Regulatory Affairs Professionals
Regulatory Compliance Professionals
Quality Assurance Professionals
Regulatory Affairs Rotational Associates

View the 2025 PMA agenda below or download it here.

Join the mailing list to receive the latest news and updates on the 2025 Workshops.

PMA Submissions Workshop

Day One

*Schedule reflects Eastern Time

Time	Session Name
8:30 – 9:00 am	Registration Check-In and Continental Breakfast
9:00 – 9:05 am	Welcome and Introductions
9:05 – 10:00 am	Beginning at the Beginning Elaine Tseng, Partner, King & Spalding When is a De Novo or PMA required – PMA: what to expect – What are the standards of evidence – What are the standards of review – Will submission go to panel – How much will it cost – How long will it take to get approval
10:00 – 10:45 am	Development of a PMA Submission Strategy Tony Blank, Senior Director of Regulatory Affair, AtriCure – Product definition – Development of testing requirements and strategy – Desired patient population – Desired claims – Early interactions with FDA – Planning for product iterations
10:45 – 11:00 am	Break
11:00 – 12:00 pm	Mechanics of PMA Quality System Submission Development and Review Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific – Defining data requirements – Required elements – Presentation of information with clarity – Expectations during review – Best practices – Manufacturing & Quality Systems – Case for Quality
12:00 – 1:00 pm	Networking Lunch
1:00 – 2:00 pm	During Submission Review Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific – Interactions with the FDA – When/How to expect questions – Types of letters – Timelines – Day 100 meetings – Labeling review
2:00 – 3:00 pm	Conditions of Approval Studies Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific – Criteria and objectives – Early collaboration with FDA – Reaching agreement – Reporting outcomes – 522 Studies
3:00 – 3:15 pm	Break
3:15 – 4:15 pm	Preparation for Advisory Panels Jessica Ringel, Partner, King & Spalding – When? – Who are the panel members? – Why have a panel meeting? – Preparation for a panel meeting – What to expect before, during, and after – Best practices
4:15- 5:15 pm	Networking Reception

Day Two

Time	Session Name
8:30 – 9:00 am	Continental Breakfast
9:00 – 10:00 am	Inspection Activity Monica Montanez, Principal Strategy Consultant, NAMSA – Pre-approval inspections – How to prepare for an inspection
10:00 – 11:00 am	Dealing with the Unexpected Tony Blank, Senior Director of Regulatory Affair, AtriCure – Clinical outcomes – Animal test results – Adverse panel recommendation
11:00 – 11:15 am	Break
11:15 am – 12:30 pm	The Care and Feeding of Approved PMAs Monica Montanez, Principal Strategy Consultant, NAMSA – Periodic (“Annual”) Reports – Supplemental Submissions – 30-day notices
12:30 – 1:30 pm	Networking Lunch
1:30 – 3:30 pm	Applied Learning and Breakout Discussions* Tony Blank, Senior Director of Regulatory Affair, AtriCure *In person participants, only – PMA Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies – Key Takeaways – Regroup for Final Program Q&A
3:30 pm	Adjournment

Join medical device submissions experts who will provide essential guidance through the PMA submission process.

Meet the Speakers

Tony Blank, Senior Director of Regulatory Affairs, AtriCure

Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).

Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific

Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation.  Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions.

Jennifer has 30 years’ Regulatory experience.  She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device.  She also works with integration projects, combination product projects, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program.  

Monica Montanez, MS, RAC, CQA, Principle Strategy Consultant – Regulatory, NAMSA

Monica Montanez has over 25 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals.

Monica began her medical device career with Millar Instruments and then with Cyberonics (now Liva Nova), CONMED, Generic Medical Devices, Inc, Cochlear and before joining Medtronic in 2010. With NAMSA, Monica then moved into consultancy where the focus of her work has always been working with manufacturers with complex submissions for novel devices. She is the in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica also holds a Master’s of Science in Regulatory Science from the School of Pharmacy University of Southern California. 

Jessica Ringel, Partner, FDA and Life Sciences, King & Spalding

Jessica Ringel advises medical device and other life sciences manufacturers and distributors on matters spanning the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations. 

Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.  She further assists life sciences firms with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA. 

Elaine Tseng, Partner, King & Spalding

Elaine Tseng is a partner in King & Spalding’s nationally ranked FDA & Life Sciences practice. Elaine draws from over 20 years working with developers of medical technologies, as well as service at the Food and Drug Administration and in-house experience, to provide strategic advice on optimizing regulatory compliance and business goals. Elaine has guided developers of digital health, diagnostic, and other device technologies in navigating the range of FDA device submissions, including 513(g)s, breakthrough device and STeP designations, IDEs, 510(k)s, De Novos, PMAs, and HDEs. Elaine also has experience with device reclassification petitions, submissions for combination products, and the regulation of human cellular and tissue-based products (361 HCT/Ps). Her work has included pursuing regulatory appeals and participating in FDA Advisory Committee deliberations. Elaine also advises on matters including responding to FDA inspections and compliance with requirements related to quality systems, labeling, adverse events and recalls, and advertising and promotion. She handles internal investigations involving these matters and also advises on structuring business transactions to minimize regulatory risk and maximize regulatory value.

Attendees joining us in person will come to AdvaMed’s office located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

This event is offered both virtually and in-person to maximize convenience. Please note that in-person and virtual pricing is the same.

Check to see if your company is an AdvaMed member here.

AdvaMed Member: $1,600
AdvaMed Accel Member: $850
Non-Members: $2,100
Government/Academic/Nonprofit: $850

Learn more about the other Medical Device Submissions Workshops focused on the 510(k) and De Novo and Investigational Device Exemption process.

510(k) and De Novo Submissions Workshop
February 3-4, 2024

Gain strategies for assembling and streamlining effective 510(k) and De Novo submissions during this interactive two-day workshop. This workshop will cover:

Different types of 510(k)s
Tips on interacting with FDA during the 510(k) review process
De Novo overview and strategy

Learn More about 510(k) and De Novo

IDE Submissions Workshop
February 7, 2024

Industry experts will share the guidelines governing when an investigational device exemption is required. Speakers will review the purpose of an IDE, share tips for making the best use of pre-submission meetings, break down the components of an IDE submission and more. This workshop will cover:

The purpose of an IDE
Components of a successful IDE submission
Common errors and deficiencies in an IDE application
Optimizing the pre-submission meeting

Learn More about IDE

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The post Medical Device Submissions Workshops – Premarket Approval (PMA) appeared first on AdvaMed.

Medical Device Submissions Workshops – Investigational Device Exemption (IDE)

Wintana Zerai — Fri, 08 Nov 2024 16:18:40 +0000

Events

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Join AdvaMed on February 5, 2025 for the Medical Device Submissions Workshop: Investigational Device Exemption (IDE)! This comprehensive workshop will provide you with in-depth guidance on the latest FDA regulations impacting the submission process and will help medtech professionals understand what’s needed for approval on their new technologies. This knowledge can expedite the journey to clinical trials and eventually to market, giving companies a competitive advantage.

The IDE Workshop offers hands-on learning through case studies, interactive discussions, and practical exercises, guiding attendees through the IDE submission process. We’re excited to offer a hybrid format that creates a comprehensive and interactive experience, while providing exclusive access to leading industry professionals for those attending in our Washington, D.C. office. If you’re new to medtech regulatory affairs, or looking to strengthen your foundational knowledge, this is the perfect event for you so register today!

Who should attend?

These workshops are valuable for anyone aiming to streamline the regulatory process, reduce submission risks, and confidently bring their device to market such as:

Medical device professionals new to the FDA regulatory submission process
Regulatory Affairs Professionals
Regulatory Compliance Professionals
Quality Assurance Professionals
Regulatory Affairs Rotational Associates

View the 2025 IDE agenda below or downloa d it he re.

Join the mailing list to receive the latest news and updates on the 2025 Workshops.

IDE Submissions Workshop

*Schedule reflects Eastern Time

Time	Session Name
8:30 – 9:00 am	Registration Check-In and Continental Breakfast
9:00 – 9:05 am	Welcome and Introductions
9:05 – 10:00 am	What Is an IDE? Tony Blank, Senior Director of Regulatory Affairs, AtriCure – Regulatory Context – When is an IDE needed? – Roles of sponsors, investigators and IRBs – The IDE Application and Helpful Tips
10:00 – 11:00 am	Developing an IDE Strategy Tony Blank, Senior Director of Regulatory Affairs, AtriCure – What to consider and when – Preclinical testing before human studies – Making the best use of pre-submission meetings – Using foreign data in a US submission – Characteristics of a successful IDE submission
11:00 – 11:15 am	Break
11:15 am – 12:30 pm	Preparing the Technical & Functional Aspects of an IDE Blake Wilson, Partner, Global Regulatory, Hogan Lovells – Elements of an IDE: Intro/Background, Manufacturing/Device, Labeling, Reference/Other – Avoiding common errors and deficiencies – The role of risk analysis in an IDE – Managing planned or unplanned device or study changes
12:30 – 1:30 pm	Networking Lunch
1:30 – 2:15 pm	Regulatory Compliance During Study Conduct Tony Blank, Senior Director of Regulatory Affairs, AtriCure – Monitoring – Consenting of patients – Enrollment requirements – Adverse event reporting – Sponsor records and reports – Investigator records and reports – Protocol deviations
2:15 – 3:00 pm	Reporting Results Blake Wilson, Partner, Global Regulatory, Hogan Lovells – Clinical study reports (interim and final) – Dissemination to the medical community and to regulators – Incorporation into pre-market submissions – Assessment of impact to product labeling – Requirements for registering trials on CT.gov
3:00 – 3:15 pm	Break
3:15 – 4:00 pm	Optimizing the Pre-Submission Meeting Tony Blank, Senior Director of Regulatory Affairs, AtriCure – What to consider and when – Preclinical testing before human studies – Making the best use of pre-submission meetings – Using foreign data in a US submission – Characteristics of a successful IDE submission
4:00 – 4:45 pm	BIMO Inspections Blake Wilson, Partner, Global Regulatory, Hogan Lovells – The purpose of a BIMO inspection – When and how a BIMO inspection occurs – Preventing findings and responding to findings – Typical and atypical observations – cautionary tales from the field
4:45 – 5:15 pm	Speaker Q&A
5:15 pm	Adjournment

Join medical device submissions experts who will provide essential guidance through the IDE submission process.

Meet the Speakers

Tony Blank, Senior Director of Regulatory Affairs, AtriCure

Blake Wilson, Partner, Global Regulatory, Hogan Lovells

Blake Wilson helps medical device, drug, and biologic companies successfully navigate FDA’s evolving regulatory landscape. With a focus on premarket submissions and clinical trial design and conduct, Blake helps sponsors plan their product development strategy and minimize regulatory risks.

When advising companies, Blake draws on years of experience practicing in front of the FDA. He has assisted clients across a wide range of submissions (e.g., presubmissions, investigational products, combination products, humanitarian/orphan products, marketing applications, breakthrough requests) with a focus on novel treatments. When feedback from the agency is needed, Blake helps sponsors craft a well-tailored regulatory strategy and is effective at presenting the plan to FDA. He also prepares sponsors for advisory panel hearings.

Attendees joining us in person will come to AdvaMed’s office located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

This event is offered both virtually and in-person to maximize convenience. Please note that in-person and virtual pricing is the same.

Check to see if your company is an AdvaMed member here.

AdvaMed Member: $925
AdvaMed Accel Member: $675
Non-Members: $1,125
Government/Academic/Nonprofit: $675

Learn more about the other Medical Device Submissions Workshops focused on the 510(k) and De Novo and Investigational Device Exemption process.

510(k) and De Novo Submissions Workshop
February 3-4, 2024

Gain strategies for assembling and streamlining effective 510(k) and De Novo submissions and obtain insight into the 510(k) and De Novo review process during this interactive two-day workshop. This workshop will cover:

Different types of 510(k)s
Tips on interacting with FDA during the 510(k) review process
De Novo overview and strategy

Learn More about 510(k) and De Novo

PMA Submissions Workshop
February 6-7, 2024

Using real-world case studies, this workshop will walk you through the practical steps of filing a PMA and offer you actionable insights on how to best navigate the PMA submission process. steps required, best practices and preparation for inspection will be covered throughout this workshop. This workshop will cover:

Steps to develop a PMA submission strategy
Preparation needed for an advisory panel meeting
Tips to prepare for an inspection
How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
Management of approved PMAs

Learn More about PMA

Hear From Us

Sign up to receive emails highlighting our upcoming events, early registration savings, and engagement opportunities for the medical technology community.

The post Medical Device Submissions Workshops – Investigational Device Exemption (IDE) appeared first on AdvaMed.

China Regulatory Workshop

Wintana Zerai — Tue, 10 Sep 2024 19:55:58 +0000

Events

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

China’s regulatory system continues to evolve rapidly to meet the growing needs of patients, providers, and manufacturers within the world’s second-largest medtech market. This workshop will take a deep dive on product registration, including various pathways and strategies. It will also dissect Order 739’s key changes to clinical evaluation and post-market surveillance since 2021. The session will also look ahead to expected changes in the next few years, based on a just-released medical devices management law draft that offers important clues.

Join AdvaMed and Biocom for this in-person workshop to enhance your understanding of China’s regulatory landscape. Grasp the key regulations, guidelines, and standards to better navigate this crucial market and shorten time-to-market.

This event is co-hosted by:

Download a copy of the full 2024 Workshop agenda

*Schedule reflects Pacific Daylight Time

Day One (Tuesday, November 19)

11:30 am – 12:30 pm

Check in & Networking Lunch

12:30 pm – 1:45 pm

The Law and Regulations and Evolution

General requirements and process for NMPA registration
The regulatory framework and evolution
Classifications and administration
Prerequisites for NMPA submission as a foreign medical device
Overview of registration approvals and trend analysis

1:45 pm – 2:45 pm

Different Types of Submissions and Strategy

Different types of submissions
- New submission for registration
- Submission for change of registration (resubmission)
- Submission for renewal without change
- Filing for Class I device
- Filing for IFU change
How to determine if a new submission rather than re-submission is necessary
How to determine when re-submission for change is needed, and if re-submission rather than a new submission is acceptable

2:45 pm – 3:00 pm

Networking Break

3:00 pm – 4:15 pm

Clinical Evaluation based on Data from Predicate Equivalent and Literature

Options and pathway for clinical evaluation
Principles for clinical evaluation based on predicate equivalency
Types and uses of clinical and non-clinical data
Strength level of clinical data as evidence
- Literature
- Real world clinical data
- Post market surveillance
- Clinical trials
When and what clinical database/raw data is required for submission
How to determine the right strategy for clinical evaluation

4:15 pm – 5:30 pm

Special Process to Expedite Pre-market Approval

Taking advantage of NMPA green channels for expedited approval
Special process for innovative medical devices
- Criteria for eligibility and processing of application
- Who would benefit more?
Preferential review & approval for products with urgent need
- Eligibility and what products are qualified
- Products for rare diseases
Special policy in Hainan province for medical device without need for NMPA registration
New Policy for urgent medical needs in Great Bay Area

5:30 pm – 6:15 pm

Networking Reception

Day 2 (Wednesday, November 20)

8:15 am – 9:00 am

Networking Breakfast

9:00 am – 10:00 am

Clinical Trials in China

How to determine if clinical trial is needed, and
clinical evaluation through predicate equivalency
could not be accepted
Submission with foreign clinical trial data without
in-China trial
Steps of conducting clinical trials in China
Quality requirement (GCP) and inspection for
clinical trial
NMPA pre-approval for clinical trial for high-risk
devices
MOST’s pre-approval for clinical study using
human genetic resource (*MOST stands for
Ministry of Science and Technology)

10:00 am – 11:15 am

Type Testing and Requirement

The legal basis for type testing
- Type test of registration
- Entrusted-commercial test
How to determine what specifications shall be
tested and can be accepted
Composite Product Technical Requirement (PTR)
o Standards mandatory or recommended for
use
- Technical guidance
- Functionality/performance claim
- Special requirement for AI device and
  medical software
Work with NMPA-accredited lab for obtaining test
report
Acceptance of test report conducted by
manufacturer’s in-house test lab or third party

11:15 am – 11:30 am

Networking Break

11:30 am – 12:45 pm

Organization, roles and workflow

Acceptance checklist of submission dossier
- Electronic submission (eRPS)
Communication process with NMPA/CMDE* before
and during review (*Center for Medical Device
Tech Evaluation)
How to fulfill the supplementary request
(deficiency) during review
Consequence if it fails to satisfy the
supplementary request, and major causes for
failure
- GCP audit
- Insufficient clinical data or failure of predicate
  equivalency
- Mandatory standard requirement
- Biocompatibility and toxicology of raw
  materials
- QMS inspection during submission and review
- Others

12:45 pm – 1:45 pm

Networking Lunch

1:45 pm – 2:45 pm

Regulatory Updates and Foreseeing Future
Development

Medical Device Regulations Amendments 2021
Expanding Market Authorization Holder (MAH)
program
Transferring import devices registered to be
“made in China”
Implementing UDI system and GSP requirement
for distributors of medical devices
Launching Hainan pilot program for Real World
Clinical Evidence
Participating international safety information
exchange (National Competent Authorities
Report, NCAR)
Exemption of Approval of Country of Origin as
prerequisite for innovative products
Clinical trial extension to benefit more patients
with urgent need
Manufacturer’s in-house test report
Pilot program for LDT (Laboratory Developed
Test) implemented
Re-test on GB9706.1 (IEC60601-1) series
standard 3rd edition
New GB or YY product standards development or
modification
Temporary import and use of non-registered
medical devices in urgent needs by medical
institute

Future Regulatory Development

More legal responsibility of local agent and
personnel
Clinical trial exemption expansion and
Multiple Center Clinical Trial
Recognition of single QMS audit
Facilitation of AI and medical robotic devices
MAH expansion to overseas manufacturer or
developer

2:45 pm – 4:00 pm

Post-market Compliance

Overseas manufacture online or on-site
inspection
Legal responsibilities of local legal agent and the manufacturer
Adverse event reporting and re-evaluation requirements:
- Understanding definition of adverse event
- When, how and who to report and reevaluate?
Annual Self-Inspection Report for Manufacturer’s
Quality Management System (QMS)
Periodic Risk Evaluation Report for device registered
Recall requirement: what, when and who shall it be reported and executed?
Post-market product test against PTR
Product labeling, advertising and distribution license

Meet the Speaker

Davey Han, M.D., M.S.

Founder and CEO of BioHan Biotechnology Consulting (Beijing) Co. Ltd., dedicating to medical device & IVDs submission, clinical evaluation, quality compliance, as well as government policy & market research in China.

Dr. Han has broad experiences from government agency, academies and the medical industry. He worked for the Chinese Academy of Medical Sciences, and National Health Economics Institute of the Ministry of Health. Then, he entered into the global high-tech medical device industry, including St. Jude Medical and Siemens Healthcare, with various key positions as regulatory affairs manager, Asian-regional senior manager, general manager of quality & regulatory affairs, and director for government & key customer relations. From 2010 to 2013, Dr. Han joined the world’s largest healthcare market research consulting firm – IMS, leading the IMS China Institute and government relations.

Registration Pricing

Click here to check if your company is an AdvaMed member*.

AdvaMed Members: $1,795*
AdvaMed Accel Members: $1,295
Non-Members: $2,225
Government/Non-Profit: $1,295

*Biocom California members qualify for the AdvaMed member rate

Event Location

This 2-day workshop will take place in Biocom California Headquarters in The Alexandria at Torrey Pines

10996 Torreyana Rd, San Diego, CA 92121

Hotel Information

Hilton La Jolla Torrey Pines

10950 N. Torrey Pines Road

La Jolla, CA 92037

Rooms are available at a discounted rate of $199 per night plus a $36 per night resort fee* and taxes. To book a room, you must register for the workshop, a link will be provided after confirmation. Sleeping rooms must be secured before October 31, 2024 and with a valid credit card and are refundable up to 3 days in advance of arrival if cancelled.

*Resort Fee includes the following amenities:

2 glasses of house wine or 2 tap beer of choice at the bar
Wi-Fi Access
2 bottles of water per day
Access to Shiley’s Sports Complex
Resort games, toys and yoga equipment
20% gift shop discount
15% off Torrey Pines Pro Shop

Hear From Us

Sign up to receive emails highlighting our upcoming events, early registration savings, and engagement opportunities for the medical technology community.

The post China Regulatory Workshop appeared first on AdvaMed.

Medical Device Submissions Workshops – 510(k) and De Novo

tajello — Mon, 12 Aug 2024 19:01:18 +0000

Events

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

AdvaMed is proud to host the Medical Device Submissions Workshops: 510(k) and De Novo in February 3-4, 2025! Choose to attend virtually or in person at AdvaMed’s Washington, D.C. office, where industry experts will provide essential guidance through the 510(k) and De Novo submission processes. Understanding the IDE process from start to finish will help reduce errors and ensure compliance with all FDA requirements. By attending this in-depth workshop, medtech professionals are better equipped to meet regulatory demands and bring their devices to market faster.

Join us to get your questions answered, discuss specific challenges, and gain expert insights into the 510(k) and De Novo application requirements to gain a deeper understanding of this essential regulatory pathway. Don’t miss this opportunity to enhance your regulatory knowledge and connect with your fellow regulatory peers!

Who should attend?

These workshops are valuable for anyone aiming to streamline the regulatory process, reduce submission risks, and confidently bring their device to market such as:

Medical device professionals new to the FDA regulatory submission process
Regulatory Affairs Professionals
Regulatory Compliance Professionals
Quality Assurance Professionals
Regulatory Affairs Rotational Associates

View the 2025 510(k) and De Novo agenda below or download it here.

Join the mailing list to receive the latest news and updates on the 2025 Workshops.

Day One

*Schedule reflects Eastern Time

Time	Session
8:30 – 9:00 am	Registration Check-In and Continental Breakfast
9:00 – 9:05 am	Welcome and Introductions
9:05 – 10:30 am	The Law and Regulations Sally Maher, Regulatory Consultant, Sally Maher Consulting – 510(k) definition – 510 and 513 FDCA – Guidance for 510(k): general & product specific – How to find it – How to use it – Different types of 510(k)s; which to use – Review of bundling 510(k)s – FDA Product Codes – Activity
10:30 – 10:45 am	Break
10:45 am – 12:00 pm	510(k) Strategy and Planning Tony Blank, Senior Director of Regulatory Affairs, AtriCure – Staff involved – Role of each function – RA responsibilities – Use of guidance – Global considerations – Pre-submissions – Predicates – Breakthrough Devices Program – Safer Technologies Program
12:00 – 1:00 pm	Networking Lunch
1:00 – 2:15 pm	Preparing the Submission Jemin Jay Dedania, Senior Director of Regulatory Affairs and Compliance at the National Evaluation System for health Technology, MDIC Melissa Hall, Founder and Principal Consultant, Statera Regulatory Consulting – General information including how to select a predicate device – Assembling the 510(k) – eCopy – eSTAR
2:15 – 2:30 pm	Break
2:30 – 3:15 pm	The FDA Review Process Alexia Haralambous, Senior Principal, RQM+ – How it works at FDA – FDA/industry interactions – Refuse to Accept – Submission Issue meetings – FDA holds – Interactive review – Least Burdensome flag – Current pilots
3:15 – 4:15 pm	Networking Reception

Day Two

Time	Session
8:30 – 9:00 am	Continental Breakfast
9:00 – 10:15 am	Clearance: Launch and After Tony Blank, Senior Director of Regulatory Affairs, AtriCure – What clearance does and does not mean – Promotional practices for 510(k) devices – FDA – FTC – Complaint Handling and MDRs – When to File a New 510(k) for Device Modifications – Catch-up 510(k)s
10:15 – 10:30 am	Break
10:30 – 11:00 am	De Novo Elaine Tseng, Partner, King & Spalding – Definition of a De Novo – Final Rule on De Novo – When De Novo is used – Differentiation from 510(k)
11:00 – 11:30 am	Regulatory Strategy for De Novo Ginny Hu, Director, Regulatory Affairs, Dexcom – Key eligibility criteria – Benefit-risk analysis
11:30 am – 12:00 pm	Preparing the De Novo Submission Bryan Osborne, Senior Manager, Regulatory Affairs, Dexcom – Content – Assembling the submission
12:00 – 1:00 pm	Networking Lunch
1:00 – 1:30 pm	FDA Review Process for De Novo Elaine Tseng, Partner, King & Spalding – Use of Pre-Submission meeting – Rationale for De Novo – Clinical Protocols – Special Controls
1:30 – 2:00 pm	Maintenance of a Granted De Novo Laura Rose, PhD, Engagement Partner, Bruder Consulting & Venture Group – Post-market requirements – Classification Order – De Novo database, granting order, decision summary – Use as a predicate – Making changes to granted De Novo device
2:00 – 2:15 pm	Break
2:15 – 4:15 pm	Applied Learning and Breakout Discussions* Tony Blank, Senior Director of Regulatory Affairs, AtriCure *In person participants, only – 510(k) & De Novo Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies & Key Takeaways – Regroup for Q&A
4:15 pm	Adjournment

Join medical device submissions experts who will provide essential guidance through the 510(k) and De Novo submission processes.

Meet the Speakers

Tony Blank, Senior Director of Regulatory Affairs, AtriCure

Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).

Jemin Jay Dedania, Senior Director of Regulatory Affairs and Compliance at the National Evaluation System for health Technology, MDIC

Jemin Dedania assists clients with regulatory and policy issues, with a focus on U.S. Food and Drug Administration (FDA) medical device and combination product strategies. He advises medical technology companies on matters related to life cycle management, promotional issues, and compliance, and provides general advice on navigating FDA’s regulatory framework. 

Jemin has worked with combination products and medical devices since completing his master’s thesis in biomedical engineering, in which he focused on novel growth factor technologies in bone healing. Upon graduating from the New Jersey Institute of Technology, he was a lead reviewer, and later a team lead, at FDA’s Center for Devices and Radiological Health in the Division of Orthopedic Devices (now the Office of Health Technology 6) for nearly eight years. He then transitioned to Stryker, where he served as a specialist and later manager in the Regulatory Affairs department. At Stryker, Jemin developed regulatory strategies for new product development projects, authored regulatory submissions, provided guidance on novel combination product submissions, interfaced with notified bodies, led advertising and promotion reviews, supported mergers and acquisition due diligence and integration efforts, and developed his staff.

Melissa Hall, Founder and Principal Consultant, Statera Regulatory Consulting

Melissa is a seasoned regulatory affairs professional with 11 years of experience, specializing in Food and Drug Adminstration (FDA) regulations for medical devices. As a former-FDA reviewer, manager, industry educator, and policy analyst, she has a deep understanding of the Agency’s position and regulatory pathways. In her current role as a regulatory consultant and advisor, she assists companies in preparing effective regulatory submissions and offers strategic communication with the FDA. Continuing her passion for industry education, Melissa is an active RAPS member who has spoken at various RAPS conferences, including most recently, RAPS Convergence about effectively utilizing eSTAR. She also serves as a regulatory advisor to various MedTech start-up companies in the Larta accelerator program. She has experience assisting clients in the cardiovascular, orthopedic, spine, ENT, ophthalmology, dental, and imaging medical device spaces.

Alexia Haralambous, Senior Principal, RQM+

Alexia is a former FDA reviewer who is an expert in medical device regulatory submissions and developing global regulatory strategies for new product development. Currently, she is a regulatory consultant with RQM+, working primarily with smaller companies and startups to get their products to market. Using a precision-based approach, Alexia supports medical device and digital health technologies in a diverse range of therapeutic areas, including but not limited to cardiovascular disease, neurology, respiratory, women’s health, urology, interventional radiology, ophthalmology, and gastroenterology.

She began her regulatory career at FDA and spent three and a half years in the spinal devices branch as a lead reviewer of premarket submissions and clinical studies. After her time at FDA, she worked at Stryker for six years, where she held roles as both a specialist and manager in the Regulatory Affairs department. At Stryker, she led teams to provide global regulatory strategies for new product development, support global compliance initiatives, and aid in sustaining production and marketing efforts. Alexia holds both a BS in Biomedical Engineering and an MS in Applied Biomedical Engineering from Johns Hopkins University.

Ginny Hu, Director, Regulatory Affairs, Dexcom

Ginny leads the RA team for digital health regulatory affairs efforts for software based products and solutions at Dexcom, including US/OUS software, data platform, APIs and data product regulatory classification, registration/approval and sustaining. Ginny’s RA team also manages partnerships and cybersecurity regulatory efforts. Her team continues to support all regulatory activities, including US/OUS regulatory pathway, breakthrough device designation, IDE, Q-subs and 510(k) submissions associated with Dexcom’s New Market initiatives.

Sally Maher, Regulatory Consultant, Sally Maher Consulting

Sally Maher is the founder of the consulting group S Maher Consulting, a premier medical device consulting organization. Ms. Maher served on the Board of Directors for ACell Inc. Previously she served as the interim Chief Operating Officer for ACell Inc. Before that she was Vice President of Regulatory and Clinical Affairs at Edwards Lifesciences, Critical Care. She has more than 30 years of medical device and combination product experience in regulatory, clinical, reimbursement, healthcare compliance, and product development.

Prior to joining Edwards, Ms. Maher held various Senior Vice President roles at Smith & Nephew’s Advanced Surgical Products Division including: Regulatory and Clinical Affairs, Reimbursement and Healthcare Economics, Healthcare Compliance, Research and Development, and New Business Development. Prior to Smith & Nephew, Ms. Maher worked in regulatory, quality, and clinical roles for various organizations including Johnson & Johnson, Pfizer, and the US Food and Drug Administration. She received a bachelor’s degree from Ohio Wesleyan University, and a law degree from the University of Baltimore.

Laura Rose, PhD, Engagement Partner, Bruder Consulting & Venture Group

Laura is a biomedical engineer who joined Bruder Consulting Venture Group after nearly 8 years at FDA. She brings a comprehensive understanding of FDA regulations, guidance, and decision-making, as well as a wealth of knowledge about regulation of devices and combination products for tissue engineering and regenerative medicine. Laura served as the Assistant Director for the Division of Restorative, Repair and Trauma Devices in CDRH’s Office of Orthopedic Devices where she led a large and diverse team of engineers, clinicians, and scientists. Although she has interacted with all corners of FDA, she worked most extensively with CBER and CDER on orthopedic combination products and is known for her calm and thoughtful approach to regulatory problem solving. Prior to joining FDA, Laura served as a co-investigator on a cell-therapy IND as a Post-Doctoral Fellow at Johns Hopkins University. Laura earned her BSc in Biochemistry from the University of British Columbia (UBC) in Vancouver, Canada, and her PhD in Biomedical Engineering from the University of Alberta in Edmonton, Canada.

Elaine Tseng, Partner, King & Spalding

Attendees joining us in person will come to AdvaMed’s office located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

This event is offered both virtually and in-person to maximize convenience. Please note that in-person and virtual pricing is the same.

Check to see if your company is an AdvaMed member here.

AdvaMed Member: $1,600
AdvaMed Accel Member: $850
Non-Members: $2,100
Government/Academic/Nonprofit: $850

Learn more about the other Medical Device Submissions Workshops focused on the Investigational Device Exemption and Premarket Approval process.

IDE Submissions Workshop
February 5, 2024

Industry experts will share the guidelines governing when an investigational device exemption is required. Regulatory leaders will review the purpose of an IDE, share tips for making the best use of pre-submission meetings, break down the components of an IDE submission and more. This workshop will cover:

The purpose of an IDE
Components of a successful IDE submission
Common errors and deficiencies in an IDE application
Optimizing the pre-submission meeting

Learn More about IDE

PMA Submissions Workshop
February 6-7, 2024

Steps to develop a PMA submission strategy
Preparation needed for an advisory panel meeting
Tips to prepare for an inspection
How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
Management of approved PMAs

Learn More about PMA

Hear From Us

Sign up to receive emails highlighting our upcoming events, early registration savings, and engagement opportunities for the medical technology community.

The post Medical Device Submissions Workshops – 510(k) and De Novo appeared first on AdvaMed.

Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

Cody Uhing — Wed, 31 Jul 2024 14:22:13 +0000

Regulatory Affairs

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.

AdvaMed Cybersecurity Summit

tajello — Tue, 23 Jul 2024 13:18:15 +0000

Events

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Medical Device Submissions Workshops – Premarket Approval (PMA)

8:30 am – 4:30 pm ET
February 6-7, 2025

Registration has officially closed for the 2024 Summit. Join our mailing list to receive updates about the 2025 Cybersecurity Summit.

Medical device cybersecurity has never been more important than it is now and as device capabilities advance and become more connected the threat landscape continues to grow. Join medical device product security experts to receive in-depth and timely updates on the state of medical device cybersecurity, including issues related to FDA requirements and cybersecurity management practices. Our 2024 Cybersecurity Summit will address the future of medical device cybersecurity as well as recent changes in the industry landscape to ensure you’re well equipped to protect your organization.

Make sure to join us for the pre-event Welcome Reception at the AdvaMed office on Tuesday, November 12 at 5:30 PM. This is an excellent opportunity to network with fellow attendees and speakers, setting the stage for the critical discussions and in-depth updates that will follow at the 2024 Cybersecurity Summit.

View the 2024 Agenda below or download a copy of it here.

Join us the day before the Summit on Tuesday, November 12 at 5:30 pm for the opportunity to meet fellow attendees, get to know our accomplished speakers and build valuable connections at our Welcome Reception in the AdvaMed Office.

Time	Session Details
8:15 – 9:00 am	Continental Breakfast and Registration Open
9:00 – 9:05 am	Welcome Remarks Anita Nosratieh, VP Technology & Regulatory, AdvaMed
9:05 – 9:55 am	FDA Regulatory Update – FY25 priorities – Implementation health check – Other timely topics Speakers: Justin Post, Policy Analyst, Cybersecurity, FDA Nastassia Tamari, Division Director, Medical Device Cybersecurity, FDA
9:55 – 10:45 am	Navigating the FDA Cybersecurity Review Process Submitting a connected device to the FDA has become significantly harder between eSTAR requirements, more deficiencies, and reviewers evaluating how manufacturers are securing devices. This session will cover the timeline for the evolution of the review process over the past several years, what manufacturers have experienced during this timeline, and common areas where manufacturers are continuing to face challenges in the review process that can result in costly review delays or negative decisions. Speakers: Matthew Hazelett, Chief Regulatory Officer, MedSec LLC Kristen Killheffer, Cybersecurity Regulatory Policy, Siemens Healthineers
10:45 – 11:35 am	Now, Who’s Being Unreasonable Here? Sorting Out Best Practices and Decision Criteria for a Reasonably Justified Regular Schedule We’ve all read it a million times since it came out: “Design, develop, and maintain processes and procedures to provide a reasonable assurance the device and related systems are cybersecure, and make available post-market updates and patches to the device and related systems to address – a) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and b) as soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks.” So, what criteria should we use to figure out the periodicity of a reasonably justified regular cycle? And what should differentiate acceptable and unacceptable vulnerabilities? The high-level answer is that the criteria should reflect the needs of: – Regulators – Our own businesses – What we would want for medical devices used by our own families In this session, we’ll discuss emerging approaches to answering these questions, as well as similar efforts in other industries. This session format will engage both panelists and audience members in an insight-rich discussion that captures the best thinking of everyone in attendance. Moderator: Randy Horton, Chief Solutions Officer, Orthogonal Speaker: Oleg Yusim, Chief Product Security Officer, Illumina Mike Nelson, VP of Digital Trust, DigitCert Jessica Wilkerson, Senior Cyber Policy Advisor, FDA
11:35- 12:25 pm	Leveraging Threat Model & Security Architecture Views for Effective Product Lifecycle Security Risk Controls Threat Modeling is both an art and a science and when mapped with accurate systemic Security Architecture representative views, the resulting symbiotic relationship can yield effective design input requirements as well as security risk control measures across the entire product lifecycle including supply chain and connected eco system. The presentation will cover how a well thought of continuous Threat Model approach can be a catalyst for any organization to derive effective risk control measures across a Secure Product Development Framework. Speaker: Sivaram Rajagopalan, Senior Cybersecurity Architect, Associate Director, Baxter Product Security
12:25 – 1:35 pm	Networking Lunch
1:35 – 2:25 pm	Securing Med Devices and the Impact of Ransomware on IoMT Growing Threat of Ransomware – Impact of ransomware attacks on med devices/networks – How to address challenges of securing connected med devices to prevent ransomware attacks – Practical examples of how Med Device manufacturers can respond to ransomware attacks involving their products Speaker: Chris Reed, Sr. Director of Cybersecurity Policy \| Global Regulatory Affairs, Medtronic
2:25 – 3:15 pm	Product Security Incident Response Team (PSIRT) – Case Study How to effectively implement PSIRT process to support cybersecurity postmarket surveillance and how to leverage other existing quality processes such as Health Hazard Assessment and Field Corrective Action (FCA). Speaker: Manan Hathi, Sr. Manager, Digital Health Regulatory Policy and Intelligence, Stryker
3:15 – 4:05 pm	Understanding IEC 81001-5-1: The New Global Standard Driving Regulatory Expectations There has been a lack of well-utilized global cybersecurity standards for medical devices for years. This led to a lack of clear alignment amongst regulators regarding what a good cybersecurity lifecycle process looks like. This has changed with the recent global embrace of IEC 81001-5-1 by many regulators across the globe. The US recognized this standard and recommends it as an accepted framework for an SPDF. The European Union has placed it on the harmonized standards list and major notified bodies are considering it mandatory. Perhaps most impactfully, Japan now requires conformance to this standard for all products sold in the country, not just for submitted products. This session will provide a foundation understanding of the standard, including notable challenge points for conformance. We will also provide clarification in certain areas of the standard that prove challenging to many users. Speaker: Michelle Jump, CEO, MedSec LLC
4:05 – 4:55 pm	Post-Quantum Cryptography: A Strategy for Medical Device Engineering Cryptanalytically relevant quantum computers (quantum computers that can break today’s asymmetric cryptography within the time the secret it guards is of value) are not a matter of if, but when. A transition to quantum-safe algorithms is a paradigm shift in the way the industry maintains the security of its operations and the safety of its patients. This transition will lead to deep engineering changes that will impact every technology stack that is used by medical devices. Compounding the problem is the overall lack of faith in these newly minted cryptographic algorithms. Contrast this with the solidity of RSA/ECC which are mature, well-studied algorithms that have withstood the test of time and countless cryptanalysts, and one begins to understand the technological risks of premature adoption of novel quantum-safe algorithms. A hybrid approach, of using both conventional as well as post-quantum crypto, provides a solid mitigator of this technical risk. Of course, that too comes with its own challenges—of supporting multiple cryptographic algorithms in the protocol suite. However, the bigger risk remains of doing nothing, of waiting till cryptanalytically relevant quantum computers become a real possibility. Speaker: Arnab Ray, Director, Product Cybersecurity, Abbott
4:55 – 5:00 pm	Closing Remarks Anita Nosratieh, VP Technology & Regulatory, AdvaMed

Join medical device product security experts to receive in-depth and timely updates on the state of medical device cybersecurity, including issues related to FDA requirements and cybersecurity management practice. Take a look at the 2024 Summit speaker lineup!

Manan Hathi, Senior Manager, Digital Health Regulatory Policy and Intelligence, Stryker

He is responsible for software and digital health regulatory policy across Stryker and has over 20 years of experience in the Medical Device space in various roles including Research, Product Development and Regulatory Affairs, with a heavy focus on software based medical devices. Mr. Hathi also serves as the software regulatory lead on the corporate product security core team, and plays an important role in the establishment, maintenance and governance of product security policies and procedures for all of Stryker Corporation.

In his role with Stryker, Mr. Hathi has been an invited speaker in several conferences and webinars with national and international forums on regulatory aspects of digital health and product security. He holds a Master of Science degree in Biomedical Engineering and is Regulatory Affairs Certified (RAC-US) by the Regulatory Affairs Professional Society (RAPS).

Matt Hazelett, Chief Regulatory Officer, MedSec LLC

Matt Hazelett is Chief Regulatory Officer at MedSec, responsible for guiding medical device manufacturers to meet and exceed regulatory requirements. His role is multifunctional and includes the direction of MedSec’s Training initiatives designed to enhance the knowledge base across the industry and set manufacturers up for success in developing and maintaining more secure medical devices.

Prior to MedSec, Matt worked at the Food and Drug Administration (FDA) for over 8 years. He most recently served as the Senior Cybersecurity Policy Analyst in the Office of Product Evaluation and Quality (OPEQ). His role focused on premarket and postmarket cybersecurity policy development and implementation across the clinical review offices including the recent requirements under Section 524B of the Food, Drug, and Cosmetic Act and the 2023 final premarket guidance. He also served as a Digital Health Center of Excellence Program Director for the OPEQ Cybersecurity Focal Point Program.

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software developer for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Randy (and Orthogonal’s) mission is to improve patient outcomes faster by accelerating the development of of SaMD by fusing the best of modern product development and software engineering practices with deep MedTech expertise in device compliance, safety and effectiveness.

Much of Randy’s career has been centered on working with healthcare and life sciences organizations from a digital transformation angle to tackle the problems summarized in The Quadruple Aim: Improving the individual experience of care, improving the health of populations, reducing the per capita costs of care, and improving the work life of those who deliver care.

Michelle Jump, MS, RAC, CEO, MedSec LLC

Michelle Jump is the CEO at MedSec, where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management. Ms. Jump has a passion for bringing technology-based solutions to healthcare, actively participating in a variety of domestic and international standards, as well as relevant industry and governmental initiatives to support security within the healthcare industry. Ms. Jump holds a Master of Science in Regulatory Science from the University of Southern California and a Master of Science in Biotechnology from California State University. She is also RAC certified and a Certified HIPAA Administrator.

Kristen Killheffer, Cybersecurity Regulatory Policy, Siemens Healthineers

Kristen Killheffer covers Cybersecurity Regulatory Policy in Siemens Healthineers’ Corporate Cybersecurity organization. In that role she tracks and monitors global cybersecurity laws and develops cybersecurity policy positions. She actively participates in numerous trade associations, health care initiatives, and in the legislative and regulatory process on behalf of Siemens Healthineers. As a part of the Governance organization within Cybersecurity, Kristen helps to drive regulatory compliance within the company’s products and has led efforts to improve cybersecurity regulatory submissions.

Before joining Corporate Cybersecurity, Kristen followed cybersecurity topics, in addition to others, as part of Siemens Healthineers’ North American Quality organization. She earned her B.A. in justice and communications studies from American University and her Juris Doctorate from Villanova University School of Law.

Mike Nelson, Global VP, Digital Trust, DigiCert

Anita Nosratieh, PhD, Vice President, Technology & Regulatory Affairs, AdvaMed

Justin Post, Policy Analyst, Cybersecurity, Office of Product Evaluation and Quality (OPEQ), Immediate Office – Digital Health, Center for Devices and Radiological Health (CDRH), FDA

Justin Post is currently a Policy Analyst (Cybersecurity) in the Immediate Office – Digital Health within CDRH’s OPEQ. The Immediate Office – Digital Health contributes to FDA’s digital health policy and to digital health related programs and activities. It also provides leadership and support to OPEQ staff with premarket and postmarket reviews in alignment with FDA guidance documents with digital health content. As part of the Immediate Office – Digital Health, Justin is primarily focused on premarket and postmarket cybersecurity policy development and implementation across OPEQ’s Office of Health Technology (OHT) 1 through 8.

Sivaram Rajagopalan, Senior Cybersecurity Architect, Associate Director, Baxter Product Security

Sivaram Rajagopalan has over 20 years’ experience in the field of Information Security & Risk Management with Big4 and Fortune 500 clients spanning multiple vertical industries including Healthcare, Medical Devices, Finance, Manufacturing, Public, Legal, Insurance, Telecommunications, IT and SMB sector. Strategic, Tactical and Operational domain expertise with wide and deep technical knowledge and experience coupled with leadership experience. Sivaram holds B.S and M.S in Electrical Engineering with several organizational accolades and security certifications.

Arnab Ray, Director, Product Cybersecurity, Abbott

Arnab Ray is the author of “Cybersecurity for Connected Medical Devices”, published by Elsevier, and is a Director of Product Cybersecurity and Manufacturing at Abbott. An author of 30 peer-reviewed journal and conference publications on software assurance and cybersecurity, he holds a PhD in Computer Science from Stony Brook.

Chris Reed, MA, CISSP, HCISPP, GCIA, Vice President, Product Security, Medtronic

An active leader supporting Medtronic’s product security programs and reports to Medtronic’s Chief Regulatory Officer. Advise product teams on cybersecurity regulatory strategy and working on key regulatory legislation/guidance/standards such as FD&C 524B. Also spent over 21 years with Eli Lilly and Company including building Lilly’s product security program supporting Digital Health including connected diabetes management products. Actively engaged as a leader in many medical device security and digital health industry initiatives such as the Healthcare Sector Coordinating Council’s Cybersecurity Working Group Executive Committee, AdvaMed Cybersecurity Working Group chair, MDIC Cybersecurity Working Group chair and various standards groups including the AAMI Device Security WG

Nastassia Tamari, Division Director, Medical Device Cybersecurity, FDA

Nastassia Tamari is the Division Director for Medical Device Cybersecurity within the Division of Medical Device Cybersecurity (DMDC), housed within the Office of Readiness and Response (ORR) in the Office of Strategic Partnerships and Technology Innovation (OST) in FDA CDRH. The Division of Medical Device Cybersecurity provides leadership and strategic direction for medical device cybersecurity policy. As part of DMDC, she leads a team which develops policy related to medical device cybersecurity to advance national preparedness and response to cybersecurity incidents involving medical devices. She spent more than a decade at a private medical device manufacture supporting the creation a product security program, leading the security operations team for enterprise, product, and manufacturing, and finally leading a global team in strategic regulatory alignment.

She earned a B.A. in Communication from San Diego State University and completed graduate work at Boston University earning an M.S. in Journalism.

Jessica Wilkerson, Senior Cyber Policy Advisor, FDA

Oleg Yusim, Chief Product Security Officer, Illumina

Check to see if your company is an AdvaMed member here.

AdvaMed Member Companies: $971
AdvaMed Accel Member Companies: $625
Government/ Non-Profit: $635
Non-Members: $1,360

Location

All 2024 Cybersecurity Summit activities will be held at the AdvaMed offices located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

Join us for:

The pre-event Welcome Reception on Tuesday, November 12 from 5:30 PM – 6:00 PM
The 2024 Cybersecurity Summit on Wednesday, November 13 from 8:15 AM – 6:00 PM

Hotel Information

JW Marriott | 1331 Pennsylvania Avenue NW, Washington, DC 20004

Our room block has officially closed!

Questions? Contact events@advamed.org.

Hear From Us

Sign up to receive emails highlighting our upcoming events, early registration savings, and engagement opportunities for the medical technology community.

The post AdvaMed Cybersecurity Summit appeared first on AdvaMed.

MedTech Reimbursement Playbook

Wintana Zerai — Wed, 17 Jul 2024 18:03:02 +0000

Regulatory Affairs

Access the playbook

We’re pleased to share AdvaMed’s first-ever MedTech Reimbursement Playbook! This course will review market access opportunities for novel technologies, explore private payer challenges, and ensure you’re able to drive positive coverage, coding and reimbursement outcomes within your organization.

With a one-time purchase you’ll have full access to this incredible resource that will leave you confident in your knowledge of the “three-legged stool” of payment—coding, coverage, and reimbursement. Sign up to receive the Playbook today!

Call to Action…

The post MedTech Reimbursement Playbook appeared first on AdvaMed.

Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development

Wintana Zerai — Fri, 12 Apr 2024 12:42:49 +0000

Regulatory Affairs

Download

Software as a medical device (SaMD) is an ever-evolving field, whether it’s the latest updates in risk classification or optimizing your use of the FDA Pre-Cert program for more iterative product development, it is important to know where you stand and what data you need to be successful. Read our white paper to “decode the confusion” in MedTech software development and keep your SaMD project on time and on budget.

Learn more.

Call to Action…

The post Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development appeared first on AdvaMed.

PFAS in Medtech

Cody Uhing — Fri, 08 Mar 2024 16:31:42 +0000

Regulatory Affairs

Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices and their packaging. PFAS can essentially be divided into two separate classes: water soluble PFAS and water insoluble PFAS.

Learn more about PFAS in medical technology in our briefing document found on this page and in the video below.

Call to Action…

The post PFAS in Medtech appeared first on AdvaMed.

AdvaMed Anticipates EtO Sterilization Rule, Voices Concern About Impact on Patient Care

Fiona Lynch — Tue, 27 Feb 2024 22:08:59 +0000

Regulatory Affairs

WASHINGTON, D.C. – By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in the United States each year. AdvaMed President and CEO Scott Whitaker released the following statement:

“Throughout this process, we’ve been clear that the draft rule, if implemented as written, could cause facility shutdowns and closures leading to widespread delays in patient care. The FDA shares this concern. If finalized as written, EPA proposals could cause up to a 50-percent reduction in EtO sterilization capacity for the medical technologies upon which patients’ health and lives depend. We appreciate the willingness of the EPA, FDA, and other agencies to hear our perspective, and we hope the final rule is more workable because they heard us. We’ll review the regulation to see if that’s the case. As we’ve said many times, the stakes are high.”

In comments filed on the draft regulation (under the National Emission Standards for Hazardous Air Pollutants, or NESHAP,) and in numerous meetings with the EPA, FDA, Office of Management and Budget, and members of Congress, AdvaMed stressed that the medtech industry welcomes the updated rule. Whitaker also testified before Congress this past fall, where he emphasized that the industry welcomes the updated regulation but that it must be rooted in science and take into account the significant negative impact a poorly written rule would have on patient care.

The industry supports updated standards while ensuring the technology patients rely on around the clock is sterile and well-supplied. The draft rule, if implemented as written, could cause disruptions in patient care resulting from facility shutdowns and closures because sterilization is at capacity.

The industry also has noted that EtO emissions have numerous sources. EtO is a naturally occurring gas and a byproduct of common, everyday items: buses, lawn mowers, fire pits, charcoal grills, and gas generators. The gas is a building block for multiple commercial products. Medical device sterilization uses half of one percent of all commercially produced EtO. In analyzing commercial sterilizer facility emissions, the EPA estimated “worst-case scenario” public health risks. Clear understanding of sources of EtO beyond commercial sterilizers and background levels are necessary to meaningful risk assessment.

# # #

Call to Action…

The post AdvaMed Anticipates EtO Sterilization Rule, Voices Concern About Impact on Patient Care appeared first on AdvaMed.

Regulatory Affairs Archives - AdvaMed

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Who should attend?

View the 2025 PMA agenda below or download it here.

Join the mailing list to receive the latest news and updates on the 2025 Workshops.

PMA Submissions Workshop

Day One

Day Two

Join medical device submissions experts who will provide essential guidance through the PMA submission process.

Meet the Speakers

Learn more about the other Medical Device Submissions Workshops focused on the 510(k) and De Novo and Investigational Device Exemption process.

510(k) and De Novo Submissions WorkshopFebruary 3-4, 2024

IDE Submissions WorkshopFebruary 7, 2024

Related Reading

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Investigational Device Exemption (IDE)

China Regulatory Workshop

Medical Device Submissions Workshops – 510(k) and De Novo

Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

AdvaMed Cybersecurity Summit

MedTech Reimbursement Playbook

Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development

Hear From Us

Medical Device Submissions Workshops – Investigational Device Exemption (IDE)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Who should attend?

View the 2025 IDE agenda below or download it here.

Join the mailing list to receive the latest news and updates on the 2025 Workshops.

IDE Submissions Workshop

Join medical device submissions experts who will provide essential guidance through the IDE submission process.

Meet the Speakers

Learn more about the other Medical Device Submissions Workshops focused on the 510(k) and De Novo and Investigational Device Exemption process.

510(k) and De Novo Submissions WorkshopFebruary 3-4, 2024

PMA Submissions WorkshopFebruary 6-7, 2024

Related Reading

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Investigational Device Exemption (IDE)

China Regulatory Workshop

Medical Device Submissions Workshops – 510(k) and De Novo

Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

AdvaMed Cybersecurity Summit

MedTech Reimbursement Playbook

Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development

Hear From Us

China Regulatory Workshop

Medical Device Submissions Workshops – Premarket Approval (PMA)

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Download a copy of the full 2024 Workshop agenda

Day One (Tuesday, November 19)

Day 2 (Wednesday, November 20)

Meet the Speaker

Registration Pricing

Event Location

Hotel Information

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Hear From Us

Medical Device Submissions Workshops – 510(k) and De Novo

Medical Device Submissions Workshops – Premarket Approval (PMA)

Gain exclusive access to industry experts who will guide you through the critical medical device submissions process step-by-step during this hybrid workshop!

Medical Device Submissions Workshops – Premarket Approval (PMA)

Medical Device Submissions Workshops – Premarket Approval (PMA)

Who should attend?

View the 2025 510(k) and De Novo agenda below or download it here.

510(k) and De Novo Submissions Workshop
February 3-4, 2024

IDE Submissions Workshop
February 7, 2024

View the 2025 IDE agenda below or downloa d it he re.

510(k) and De Novo Submissions Workshop
February 3-4, 2024

PMA Submissions Workshop
February 6-7, 2024

IDE Submissions Workshop
February 5, 2024

PMA Submissions Workshop
February 6-7, 2024