Medical Device Submissions Workshops – Premarket Approval (PMA)
8:30 am – 4:30 pm ET
February 6-7, 2025
Gain exclusive access to FDA and 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 is open for the Medical Device Submissions Workshop: Premarket Approval (PMA) happening February 6-7, 2025! This workshop will connect attendees with FDA representatives and 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 preliminary 2025 PMA agenda below or download it here.
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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 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 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 |
Day Two
| Time | Session Name |
|---|---|
| 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 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 – 2:15 pm | CDRH Ombudsman’s Office – Roles & Responsibilities – The Appeals Process |
| 2:15 – 2:30 pm | Break |
| 2:30 – 4:30 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 |
| 4:30 pm | Adjournment |
Join medical device submissions experts and FDA officials who will provide essential guidance through the PMA submission process
Meet the Speakers
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.
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 and obtain insight into FDA’s perspective on the 510(k) and De Novo review process during this interactive two-day workshop. This workshop will cover:
- FDA guidance for 510(k)
- 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 7, 2024
FDA and industry experts will share the guidelines governing when an investigational device exemption is required. Experts 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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