I feel like the FDA requires that forms be controlled documents, but I can't find a regulation stating that.  AABB includes forms in their definition of documents, but I can't find anything similar in the FDA regulations.  FDA used to have a Guidance for inspections, but I can't find that either.   Any pointers appreciated. 

The FDA's Guidance for inspections is super cumbersome to get through, and is very much written for inspectors, not those looking for info on what is to be inspected. I went through it once a few years ago....never again. Lol. 

I agree that there isn't a clear direction on if forms are controlled documents, but I've always handled forms as an attachment or part of an SOP/document, so they also get the document control revision dates and such, including retention of old versions for the same timeframe that old procedures are retained. Implied best practice, I guess? Hope that helps!

Thanks.  That does seem like a good system. 

That brings up the next question.  Does FDA expect every form to have an associated procedure?  AABB does. TJC doesn't.  Although we adhere to most of the AABB standards, we are no longer accredited by them so now I need to know what FDA requires.

Same! We were AABB accredited long ago, so still follow the standards, just not quite to such a rigorous degree. We are now TJC and FDA inspected. To my knowledge, FDA doesn't require an associated procedure the way AABB does. As long as there is document control for everything, I think you're covered. I've been in my job 10 years with this inspection setup and not had any issues with my procedures or policies with FDA.