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Day Three – 12 June 2024 - CEST (Cent Europe Summer, GMT+2)
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Day Three – 12 June 2024 - CEST (Cent Europe Summer, GMT+2)
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Regulatory Affairs in Global Markets: US Region
08:30 - 08:40
Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets: US Region
- Jeff Shapiro - Partner, King & Spalding
- Kim Kaplan - Senior Product Manager, ISACA
08:40 - 09:00
Overview of US FDA Regulation of Medical Devices
- About FDA and the Center for Devices and Radiological Health (CDRH)
- Definition of a Medical Device (Intended Use, Technology)
- Jeff Shapiro - Partner, King & Spalding
09:00 - 09:30
Primary Routes to US Market
- Premarket Notification – Traditional, Abbreviated, Special
- 510(k) Exemption
- De Novo Classification
- Premarket approval (PMA)
- Modules, modular and full submissions
- 513(g) Request for Classification
- Jeff Shapiro - Partner, King & Spalding
09:30 - 10:30
A Closer Look at Premarket Notifications and De Novo Requests
- Breakthrough Designation and Step Program
- The 510(k) Process, Different types of 510(k)
- Predicate Devices & Substantial Equivalence
- Contents of a 510(k) submission
- The De Novo Process & Drafting De Novo Requests
- Post-market Device Modifications
- Jeff Shapiro - Partner, King & Spalding
10:30 - 10:40
A Closer Look at Premarket Approval (PMA) Applications
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Advisory Panels
- Manufacturing Inspections
- Modifications to Approved Devices
- Jeff Shapiro - Partner, King & Spalding
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Regulatory Affairs in Global Markets: US Region
11:10 - 11:55
Making The Most of Q-Submissions
- What is Q-submission (or ‘pre-submission’)
- When is it helpful?
- How to Prepare the Q-Sub Package for FDA
- How to Prepare for the Feedback Meeting
- FDA Feedback & Follow Up
- Jeff Shapiro - Partner, King & Spalding
11:55 - 12:40
General Postmarket Requirements
- Manufacturing Requirements
- Quality System Regulation: 21 C.F.R. Part 820
- A Look at Upcoming Harmonization with ISO 13485
- Complaint Handling and Medical Device Reporting: 21 C.F.R. § 820.198, Part 803
- Conducting and Reporting Recalls: 21 C.F.R. Parts 7 and 806
- Jeff Shapiro - Partner, King & Spalding
Showing 1 of 1 Streams
Regulatory Affairs in Global Markets: US Region
13:55 - 14:00
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets: US Region
- Jeff Shapiro - Partner, King & Spalding
- Kim Kaplan - Senior Product Manager, ISACA
14:00 - 14:45
Product Development US Style
- Determining proposed indications for use
- Formulating a regulatory strategy – premarket pathway and predicate device
- Preparing a verification and validation testing plan
- Seeking feedback from FDA
- Assembling the premarket submission
14:45 - 15:30
Voluntary Improvement Program (VIP)
Device makers enrolled in the Voluntary Improvement Program (VIP), a part of the FDA’s Case for Quality initiative, have learned to design, build and deliver safer products to patients faster by shifting to a continuous improvement mindset. VIP focuses on quality, so attendees will learn how shifting from tactical to strategic thinking, and pursuing systemic changes in their programs, will deliver lasting benefits beyond addressing individual problems.
- Kim Kaplan - Senior Product Manager, ISACA
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