The FDA’s New Draft Guidance on Medical Device Change(s) and the 510(k)
Online Event
Palo Alto CA
Why Should You Attend:
The FDA has published a New Draft Guidance Document, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”, on July 27, 2011, that shows how companies are to perform meaningful, results driven 510(k) / change analysis activities. However, companies are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. Read more »