Medical Device Submissions Workshops – Investigational Device Exemption (IDE)
8:30 am – 5:15 pm ET
February 5, 2025
Gain exclusive access to FDA and industry experts who will guide you through the critical IDE medical device submissions process step-by-step!
Medical Device Submissions Workshops – Investigational Device Exemption (IDE)
8:30 am – 5:15 pm ET
February 5, 2025
Medical Device Submissions Workshops – Investigational Device Exemption (IDE)
8:30 am – 5:15 pm ET
February 5, 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 the FDA and leading industry experts 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 preliminary 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
*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? Anne Talley, Chemical Engineer, FDA – 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 Kristin Zielinski Duggan, Partner, Global Regulatory, Hogan Lovells – Monitoring – Consenting of patients – Enrollment requirements – Adverse event reporting – Sponsor records and reports – Investigator records and reports – Protocol deviations |
| 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 – 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 |
| 2:15 – 3:00 pm | Reporting Results Kristin Zielinski Duggan, 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 Amrin Chowdhury, Health Scientist, FDA – 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 and FDA officials who will provide essential guidance through the IDE submission process.
Additional speakers will be added soon. Join our mailing list to be notified when all speakers are announced.
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).
Amrin Chowdhury, Health Scientist, FDA
Amrin Chowdhury is a Health Scientist for the Division of Clinical Policy and Quality and within the Office of Clinical Evidence and Analysis (OCEA) at the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). She joined the FDA in 2022 serving as a Policy Analyst within OCEA. Prior to joining the FDA, Amrin served as a Project Manager at the Foundation of the National Institutes of Health (FNIH). She was part of a team overseeing a major non-small cell lung cancer (NSCLC) umbrella clinical trial, Lung-MAP. Amrin received her MS in Health Science from George Washington University.
Kristin Zielinski Duggan, Partner, Global Regulatory, Hogan Lovells
With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For over 25 years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, and combination products.
Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years – including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels – Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date.
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.
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 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
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
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