26/27 May 2021
On 31 December 2012, the FDA published three new Guidances in order to facilitate the submission process for medical devices in the USA. Two guidances concern 510k- and PMA-documents, the third one gives further guidance on an "eCopy Program for Medical Device Submissions".
The guidance "Refuse to Accept Policy for 510(k)s" explains the procedure and especially the criteria, the FDA expects in order to assess whether a 510(k) submission can be accepted for substantive review. With 79 pages it is a very long document. Starting on page 17, detailed acceptance checklists are described for a traditional, an abbreviated and a special 510k-procedure.
In principle, somewhat comparable to the guidance mentioned above, the guidance "Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)" identifies the criteria that have to be met so that the FDA will accept a PMA submission. The guidance also addresses the preclinical and clinical issues that are part of a PMA. The review process is explained, too. This guidance consists of 31 pages and is also characterised by checklists (such as "Checklist for Acceptance Review for PMAs").
The guidance "eCopy Program for Medical Device Submissions" explains a new program, the so-called "electronic copy (eCopy) Program" for the submission of medical devices. This guidance describes how the FDA is implementing the eCopy Program and provides the standards for a valid eCopy-system. The guidance is composed of 25 pages that often are structured in questions and answers. The pages 13 et seq. contain an attachment on standards for eCopies.
All three guidances are directed to industry as well as to FDA itself.