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.

I particularly find section 2.2.1 to be open to interpretation:

“A 510(k) may not be needed if the manufacturer has satisfactory results from the testing indicated by ISO 10993-1 in its files for the material in question or if such results are available to the manufacturer, e.g., are available in the open published literature or have been provided to the 510(k) holder by the material supplier. Applying this principle is much clearer for materials such as metal alloys, where the physical and chemical descriptions for a particular formulation are exact, than it is for materials such as polymers or ceramics, where the characterization of the formulation may be less exact and there may not be a good correspondence between the material formulation intended for use in the device and that formulation for which the results of testing are well established. In this latter instance, additional testing (in the sense of this guidance) is probably necessary.

However, if such additional testing is required, a 510(k) is usually necessary. Note that if testing of the original cleared device was done according to prior FDA guidance (Tripartite Agreement), further testing is necessary only if the manufacturer decides that there are new aspects to the material suggested by ISO 10993-1 that the previous guidance did not suggest.”

I am interested in how this section will be rewritten, especially in light of the FDA's recent focus on biocompatibility.

I feel that it would also be helpful if the FDA broadened the scope of the guidance to include what they expect to see in an internal 510K assessment. In my experience, different companies can have wildly different internal 510K processes. I would like to see the new guidance not only clearly explain when to submit a 510K, but also specifically describe what is needed when you don’t submit. But that's just what I am thinking about today. What do you think?

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