The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.
[fa icon="clock-o"] 5/29/13 5:09 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Medical Devices, medical device industry, FDA, K97-1, Guidance Document, regulatory, 510(k)
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