ARTICLE SUMMARY:
FDA takes a step toward mandatory electronic PMAs. Excerpted from Pathways Picks September 21: PMA eSubmissions, GRAIL Panel, China AI Study Guide, and More
FDA took a key step toward eventually mandating electronic-only submissions of PMAs with a September 17 draft guidance. The draft outlines procedures and standards for compiling a PMA submission within the electronic Submission Template and Resources (eSTAR) and once it is finalized it will include a specific timetable for transitioning to mandatory submission of PMAs and PMA supplements via eSTAR and the CDRH online portal, rather than paper and an eCopy (flash drive, etc.).
It’s the same path the agency took for 510(k)s and De Novos, which now must be submitted electronically. FDA also issued a similar draft guidance for Q-Submission (including Pre-Submissions) last year, but it has yet to be finalized. At the moment, firms can voluntarily use eSTAR for PMAs. Notably, the draft guidance outlines several elements of the PMA process that will be exempt from the eSTAR electronic submission mandate, including interactive review
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