Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

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