Dear Forum colleagues
Can anyone please advise on the FDA’s preferred means of updating Device Master Access Files (MAFs)? The aim is to allow amendments to the submitted confidential information while retaining the original MAF Reference Number as far as possible. To clarify, how does FDA prefer to receive the revised information while maintaining easy navigation – e.g. rip and replace a whole section or chapter; or a line-by-line revision; or some other format or method? Alternatively, if the amendment / revision is sizeable - for instance, when introducing an additional variant - would an altogether fresh MAF to replace the previous submission (i.e. new MAF Reference Number) be the option preferred by FDA?
Your experiences, recommendations and guidance is much appreciated.
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Homi Dalal RAC
Regulatory Affairs Leader
Dynamic Controls
Christchurch
New Zealand
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