Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Instructor:
Cheryl Wagoner
Product ID: 703438
- Duration: 60 Min
Why Should You Attend:
The goal of a 510(k) application is to demonstrate substantial equivalence. Historically, it was common to use multiple predicates to show substantial equivalence of a new device. More and more, it is preferable to rely on a single predicate or at least the fewest number possible. It is still appropriate at times to have multiple predicates, but one must exercise caution in order to not give the impression the subject device is not very similar to other marketed devices.
This webinar will discuss search techniques for identifying appropriate predicates for a 510(k) application. It will provide tips and techniques on how to determine a predicate or multiple predicates that are suitable for supporting a decision of substantial equivalence.
Areas Covered in the Webinar:
- What should be the basis of the predicate?
- When is it appropriate to have multiple predicates?
- When is it not appropriate to have multiple predicates?
- You must have head-to-head comparative test data?
- How can I use standards to demonstrate equivalency?
- Search tips for identifying a predicate for your device.
- How do you get enough information to determine if your device is substantially equivalent?
Who Will Benefit:
- Regulatory Managers or Project Managers
- Regulatory Specialists who Compose 510(k) Applications
- Product Development Managers or Project Managers
- Quality Systems Personnel
- Engineering/R&D/Technical Services
Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.
Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.
More Training By Experts
- Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
- Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
- Creating a Global Regulatory Plan
- How to file a 510(k) when your device is (or contains) software
- Is your Essential Requirements Checklist (ERC) up to snuff?
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