FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP)

[Chrisx]

Re: FDA encourages industry to participate in Medical Device Single Audit Program (MD

I agree neither approach for calculating audit duration is satisfactory. IMO, the IAF guidance provides inadequate audit duration for small companies. The MDSAP guidance does not seem to take into account many factors that should be considered in the determination. Neither approach is adequate.