ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA takes step toward mandatory electronic PMAs; congressional watchdog looks at FDA third party reviewers; an advisory panel support GRAIL’s cancer-screening PMA; FDA commissioner nominee heads to the Hill; China issues guides on AI clinical evaluation, good manufacturing practices, and real world data quality; and more medtech policy updates.
FDA Picks
The US agency progressed on electronic submissions and it was scrutinized for its third party review program efforts. It is also a busy meeting week, with a closely watched advisory panel meeting and a hearing on Capitol Hill:
PMAs’ electronic future
FDA took a key step toward eventually mandating electronic-only submissions of PMAs with a September 17 draft guidance.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 FDA also issued a similar draft guidance for Q-Submission (including Pre-Submissions) last year, but it has yet to be finalized.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 Notably, the draft guidance outlines several elements of the PMA process that will be exempt from the eSTAR electronic submission mandate, including interactive review responses, appeals, withdrawal requests, and mandatory annual reports.
