Medical Device Submissions Series: Premarket Approval (PMA) Workshop
8:30 am – 4:30 pm ET
February 6-7, 2025
Sharpen your PMA submission skills to confidently navigate this complex submissions pathway
Medical Device Submissions Series: Premarket Approval (PMA) Workshop
8:30 am – 4:30 pm ET
February 6-7, 2025
Medical Device Submissions Series: Premarket Approval (PMA) Workshop
8:30 am – 4:30 pm ET
February 6-7, 2025
Join AdvaMed’s Medical Device Submissions Series: PMA Workshop to gain practical, expert-led guidance from industry leaders on navigating this complex regulatory pathway. Designed for medtech regulatory, clinical, and product teams, this workshop delivers hands-on instruction for building strong PMA applications, aligning with FDA expectations, and reducing the risk of delays or rejections to help your technologies reach the market faster.
The workshop also emphasizes strategic planning, cross-functional collaboration, and regulatory best practices, giving you the tools to streamline submissions and confidently manage complex regulatory requirements. Make sure you’re in the room for this engaging workshop with medtech experts and peers. Sign-up to receive programming updates.
Key Takeaways Include
- How to structure a strong PMA submission that meets FDA expectations
- Strategies to anticipate and address common pitfalls that can delay approval
- Guidance on leveraging pre-submission meetings and FDA interactions to your advantage
- Practical steps for managing clinical and regulatory documentation throughout the PMA process
View the 2026 PMA agenda below or download it here.
PMA Submissions Workshop
*Schedule reflects Eastern Time
| February 26 | |
|---|---|
| 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 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 – 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 – 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 – 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 – 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 – 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 Speaker Jessica Ringel, Partner, King & Spalding |
| 4:15 – 5:15 pm | Networking Reception |
| February 27 | |
|---|---|
| 8:30 – 9:00 am | Continental Breakfast |
| 9:00 – 10:00 am | Inspection Activity Pre-approval inspections How to prepare for an inspection |
| 10:00 – 11:00 am | Dealing with the Unexpected Clinical outcomes Animal test results Adverse panel recommendation Speaker Tony Blank, Senior Director of Regulatory Affairs, AtriCure |
| 11:00 – 11:15 am | Break |
| 11:15 am – 12:30 pm | The Care and Feeding of Approved PMAs – Periodic (“Annual”) Reports – Supplemental Submissions – 30-day notices |
| 12:30 – 1:30 pm | Networking Lunch |
| 1:30 – 2:15 pm | CDRH Ombudsman Program – Confidential, independent, impartial resource for resolving disputes – Formal appeals process (21 CFR 10.75) |
| 2:30 – 4:30 pm | Applied Learning and Breakout Discussions – PMA Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies – Key Takeaways – Regroup for Final Program Q&A Speaker Tony Blank, Senior Director of Regulatory Affairs, AtriCure |
| 4:30 pm | Adjournment |
Registration
AdvaMed members receive the best pricing on our signature events. Check to see if your company is a member here.
Please note: Both online and in-person options are offered at the same rate, allowing you to choose the format that suits your needs.
Registration Rates
- AdvaMed® Member Companies: $1,700
- AdvaMed Accel® Member Companies: $900
- Government/ Non-Profit: $900
- Non-Members: $2,200
Have questions? Contact us to get support.
Location
This event is offered both online or in-person in Washington, D.C.
The PMA Workshop will be on Thursday, February 26 – Friday, February 27 at the AdvaMed office, 1301 Pennsylvania Ave NW, Washington, D.C. 20004.
Housing
If you’re joining us in Washington, D.C, there are several convenient hotel options nearby to accommodate your stay. Please note that AdvaMed does not have a room block for this event, so pricing and availability will vary by property. We encourage attendees to book early to secure the best rate.
Explore the other Medical Device Submissions Workshops focused on the 510(k) & De Novo and Investigational Device Exemption pathways.
510(k) & De Novo Submissions Workshop
February 23-24, 2026
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
IDE Submissions Workshop
February 25, 2026
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
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