Receive expert guidance to navigate every stage of the 510(k) & De Novo, IDE, and PMA submissions pathways.
510(k) & De Novo: Tuesday, February 9 – Wednesday, February 10, 2027
IDE: Wednesday, February 17, 2027
PMA: Tuesday, February 23 – Wednesday, February 24, 2027
AdvaMed Medical Device Submission Workshop Series
February 9, 2027 – February 28, 2027
AdvaMed Medical Device Submission Workshop Series
February 9, 2027 – February 28, 2027
AdvaMed’s Medical Device Submissions Series connects regulatory, clinical, and product teams with FDA experts and senior industry practitioners across three separate workshops covering the 510(k) & De Novo, IDE, and PMA pathways. Each workshop combines real case studies, interactive sessions, and authoritative guidance on what it takes to get submissions right.
The series begins with the 510(k) & De Novo Workshop from February 9-10, 2027 designed for professionals across the full regulatory team. Attendees gain an in-depth look at FDA regulations, submission strategy, and the review process designed for professionals at every experience level, from first-time submitters to seasoned practitioners. The IDE Workshop on February 17 and the PMA Workshop, February 23-24 follow, providing comprehensive coverage across every major FDA premarket pathway. Whether your organization is navigating a first submission or managing an active one, each workshop delivers the same combination of FDA access, real case scenarios, and senior industry expertise.
Attend the session most relevant to your organization, or register for multiple workshops to strengthen your regulatory submissions foundational knowledge.
Register now and receive a discount for attending multiple workshops.
Why Attend
FDA’s submission requirements don’t stand still and neither can the teams responsible for navigating them. The Submissions Workshop series is built for regulatory professionals who need to move beyond the guidance documents and into practice.
The 2027 program focuses on how submission decisions actually get made by industry teams building the strategy, preparing the package, and managing the review — and by FDA staff evaluating it on the other side.
View the 2027 510(k) and De Novo program below
*Schedule as of 6/24/2026
| Session | Session Description |
|---|---|
| The Law and Regulations | – 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 |
| 510(k) Strategy and Planning | – Staff involved – Role of each function – RA responsibilities – Use of guidance Global considerations – Pre-submissions – Predicates – Breakthrough Devices Program – Safer Technologies Program |
| Preparing the Submission | – General information including how to select a predicate device – Assembling the 510(k) – eSTAR |
| The FDA Review Process | – How it works at FDA – FDA/industry interactions – Refuse to Accept – Submission Issue meetings – FDA holds Interactive review – Least Burdensome flag – Current pilots |
| CDRH Ombudsman Program | – Confidential, independent, impartial resource for resolving disputes – Formal appeals process (21 CFR 10.75) |
| Clearance: Launch and After | – 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 |
| De Novo | – Definition of a De Novo – Final Rule on De Novo – When De Novo is used – Differentiation from 510(k) |
| Regulatory Strategy for De Novo | – Key eligibility criteria – Benefit-risk analysis |
| Preparing the De Novo Submission | – Content – Assembling the submission |
| FDA Review Process for De Novo | – Use of pre-submission meeting – Rationale for De Novo – Clinical Protocols – Special Controls Benefit-Risk Considerations |
| Maintenance of a Granted De Novo | – Post-market requirements – Classification Order De Novo database – Granting order, decision summary – Use as a predicate – Making changes to granted De Novo device |
| Applied Learning and Breakout Discussions | – 510(k) & De Novo Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies & Key Takeaways – Regroup for Q&A |
Meet the industry and FDA leaders who will guide you through the IDE Submissions pathway.
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 withAdvaMed®. 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).
Amrin Chowdhury, Health Scientist, FDA
Amrin Chowdhury is a Health Scientist in CDRH’s Office of Clinical Evidence and Analysis (OCEA) at FDA. She joined the FDA in 2022 serving as a Policy Analyst within OCEA and currently, a member of the CDRH Bioresearch Monitoring Program (BIMO). Her work in BIMO focuses on bioresearch monitoring review and directing inspection of Premarket applications, which can include Premarket Approval Applications (PMAs), Premarket Notifications (510ks), Humanitarian Device Exemptions (HDEs), and De Novos. Prior to joining the FDA, Amrin served roles as a Project Manager, Clinical Research Associate, and Data Manager for various Phase I – Phase III drug clinical trials across different organizations, including Foundation for the National Institutes of Health, Leidos Biomedical, Inc., and EMMES Corporation.
Amrin received a bachelor’s degree in biology from George Mason University and a master’s in health science from George Washington University.
Anne Talley, Chemical Engineer, FDA
Anne Talley is a Chemical Engineer in the Division of Clinical Policy and Quality within the Office of Clinical Evidence and Analysis (OCEA) in the Center for Devices and Radiological Health (CDRH) at FDA. Anne has over 7 years of experience at FDA, both as a Lead Reviewer/Team Lead in the Office of Orthopedic Devices (OHT6) and within OCEA.
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.
Leveraging his prior experience in clinical research and biostatistics, Blake advises sponsors on study design considerations and reporting study outcomes. By stress testing clinical evidence through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project. He also prepares sponsors for FDA Bioresearch Monitoring (BIMO) audits, and can host the inspection. Whether crafting a regulatory strategy, preparing a submission, or negotiation a solution with the agency, Blake provides technical acumen and creativity to help companies achieve their goals.
Blake also advises on due diligence and other corporate matters related to medical products (e.g., mergers and acquisitions). He also assists companies with compliance challenges, including government and internal investigations, and 483 and Warning Letter responses.
While at Penn Law, Blake was an executive editor for the Journal of International Law and published a comment regarding the use of foreign clinical trials in the FDA’s drug marketing approval process. He also served as a judicial intern to the Honorable Leonard P. Stark of the U.S. District Court for the District of Delaware. Prior to becoming a lawyer, Blake was a lead research assistant at Brown University, where he managed phase I and II pharmaceutical clinical trials; he later went on to obtain a master’s degree in biostatistics from Columbia University.
Explore the other workshops in AdvaMed’s Submissions series covering the IDE and PMA submissions pathways.
IDE Submissions Workshop | Wednesday, February 17
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
PMA Submissions Workshop | Tuesday, February 23 – Wednesday, February 24
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:
- Management of approved PMAs
- 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
RAPS Approved Provider
AdvaMed® is a RAPS Approved Provider. This educational program meets the RAC recertification requirements to maintain the credential. For more information about the RAC, visit www.raps.org/rac.
Credit: The IDE Workshop has been approved for up to 6 RAC recertification credits for attendees.
Registration
AdvaMed® members receive the best rates so check to see if your company is a member here.
510(k) & De Novo Workshop
- Accel Start-ups (Revenue 1 – $100M): $600
- Emerging Medtech (Revenue 1 – $100M): $600
- Large Medtech Member (Revenue > $100M): $1,300
- Non-Member: $1,600
- Academic: $600
- Gov’t/Non-Profit: $600
IDE Workshop
- Accel Start-ups (Revenue 1 – $100M): $500
- Emerging Medtech (Revenue 1 – $100M): $500
- Large Medtech Member (Revenue > $100M): $700
- Non-Member: $900
- Academic: $500
- Gov’t/Non-Profit: $500
PMA Workshop
Gov’t/Non-Profit: $600
Accel Start-ups (Revenue 1 – $100M): $600
Emerging Medtech (Revenue 1 – $100M): $600
Large Medtech Member (Revenue > $100M): $1,300
Non-Member: $1,600
Academic: $600
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