In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail in a thumb drive or DVD, but gone are the days of bulky folders of paper and all those dividers and tabs. We take a look at FDA requirements.
Anyone who has filed a 510(k) knows that the last step can be one of the more painful. All that hard work of document preparation comes down to several days of careful printing, collation, bindings and fitting in all those little tabs to make the whole thing look just so. And FDA handles a lot of paper – with many hundreds of submissions received each year the agency has become very prescriptive about how it likes to receive things. Submissions need to be set out into chapters and sections, with everything carefully paginated and cross-referenced. All of this is placed in ring binders which are sent at great expense by courier to Maryland.
For some years now FDA has allowed the required second and third copies to be “eCopies”, digital versions which can be included in the package. But they have to be IDENTICAL to the paper original. The only exception being things like spreadsheets, database files or other digital formats which have no paper equivalent (they have to be readable by FDA of course).
Finally, FDA has decided it doesn’t need the paper copy at all. In the proposed rule, it will be permissible to send 510(k), PMA and other filings to FDA as digital versions only. After all, FDA has long ago moved to storing the eCopies on internal file servers allowing reviewers easy access to the whole submission. Long gone are the days of dividing up the chapters for the different expert reviewers to peruse independently.
But don’t expect that this change will make submission acceptance any easier. FDA’s application of its refusal to accept policies has been notoriously obsessive, with submissions being returned for things like a missing underscore in an eCopy file name. So it’s important to understand the FDA’s very specific formatting rules and to follow them scrupulously. Otherwise, that’s not a submission – it’s an expensive boomerang.
Link to FDA proposed rule.
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