Draft Guidance document compliance mandatory to avoid a RTA?



Dear Experts,

Kindly help me with the following question:

I am working with a medical device for which a number of FDA's guidance documents are applicable. Some of the guidance documents are final while others are in "draft" stage.

I understand that whenever FDA has a guidance document for a particular device, there is an expectation that the Manufacturer should comply with all the applicable sections of the guidance document, else it is quite possible that the Manufacturer might receive an RTA. However, I was wondering if the same rule applies for a draft guidance document. Are Manufacturers expected to comply with all applicable sections of a draft guidance document as well, in order to be meet FDA's expectation and smoothly go through the "Refuse to expect" checkpoint.

I would really appreciate your help. :thanks:



The answer is a definite "maybe".

Some examiners will expect Draft Guidances to be followed...either in a situation where there was no prior guidance, or where there was a prior guidance that is being superceded.

You can push back on that, but my experience has been that pushback against FDA is usually counter-productive.

Note that occasionally a Draft Guidance will include in its preamble a statement regarding its effectivity. The Draft Guidance issued last August 1, for instance, was stated to be effective immediately in regard to FDA operations, even though not formally adopted yet.


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guidance documents (whether draft of final) represent the CURRENT thinking of the agency. that "thinking" is often established before guidance documents are published so in many cases expectation of the FDA reviewer will be there.
If you have a good reason not to follow the guidance, then raise the question or propose a different solution.

keep in mind that a guidance document is an interpretation of a regulation, not a regulation itself.
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