MDSAP vs "Full" FDA Requirements?



Hi all,

Please can someone tell me the difference between the FDA requirements for Medical Device/IVD manufacture; regarding MDSAP and the CFR regulations.

Ie, if we do a gap analysis against MDSAP, are we essentially "FDA compliant" or are there additional clauses outside of MDSAP that we need to address?

As a background, we have an upcoming MDSAP audit (which we are currently prepping for) but we also want to make an application to list our site/product with the FDA later in the year...

Just want to make sure there isn't a duplication of effort here...

Cheers :)

HUGE thank you in advance.


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MDSAP is an auditing methodology, not a set of regulations or requirements.

To ensure compliance with the FDA requirements, you should do a gap analysis to 21 CFR 801, 806, 807, and 820.
There may be others applicable too, depending on the type of your product.
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