Where did FDA 510(K) form 3654 go?

[SSchoepel]

I am doing a new 510(k) and wanted to make sure I'm using the latest version of form 3654 but it seems to be gone. Anyone know anything about it?

It isn't in the forms list anymore. FDA Forms

 

[Ronen E]

It's no longer required, see slide 9 at the bottom.

https://www.fda.gov/downloads/Training/CDRHLearn/UCM624332.pdf

 

[Madhubnvs]

I am doing 510 (K) for an implant device, some of the biocompatibility testing is not carried out for the device but through literature route demonstrated its compliance. Now do I need to show these standards as well in the Declaration of Conformity? Please suggest

 

[monoj mon]

Now do I need to show these standards as well in the Declaration of Conformity?

In my opinion you don't need to show it. I am assuming that while conducting the evaluation for compliance based on the literature route (in the same document) you must have mentioned those standard also which you followed for the rest of the biocompatibility end points. While preparing the declaration of conformity, refer that evaluation document and attach it during the submission.

 

[Madhubnvs]

Thanks for the reply. Also would like to ask for ISO 10993-11: Biological evaluation of medical devices — Part 11: Tests for systemic toxicity, as we have not conducted testing for the sub-chronic toxicity but we do have reports for systemic toxicity. Then we should mention the clause only for the systemic toxicity in the declaration of conformity document saying that we have reports only for this