ARTICLE SUMMARY:
CDRH issued its annual guidance priorities in mid-October, listing 18 guidance topics designated as “A-list” or “B-list” final or draft guidance priorities. Excerpted from Pathways' Picks October 19: CMS Rules, EU Meet-Up, FDA Guides, UK Picks and More.
The Breakthrough Devices Program, post-COVID-19 transitions, cybersecurity, and devices for opioid-use disorder are among the topics that will be prioritized for attention by CDRH guidance documents in FY 2023. FDA’s device center issued its annual guidance priorities October 17, listing 18 guidance topics designated as “A-list” or “B-list” final or draft guidance priorities. CDRH says it published 13 of the 23 guidances that were included on the list last year. Six of those were draft guidances that now appear as final guidance priorities, and there are several carryover documents that haven’t been published since last year’s list. But there are a few new additions to the list including:
- A general revision of FDA’s Breakthrough Device guidance (A-list final guidance): FDA has previously signaled plans for a targeted update to the Breakthrough guidance focused on healthcare disparities, which could be issued any day (see below). But the latest list seems to suggest broader updates are coming.
- De Novo electronic submissions template (A-list draft): FDA has already opened up its eSTAR platform to De Novo submissions so it is not surprising that the agency is developing a guidance for employing the PDF-based template in this context. And, as with 510(k)s, FDA will eventually use this guidance to communicate when eSTAR will be required for De Novos.
- Chemical analysis for biocompatibility (B-list draft): Biocompatibility remains one of the biggest trouble spots for companies in submissions to FDA and this draft would get at one important element of that issue.
- ASCA guides (B-list drafts): CDRH added three draft guidances addressing the Accreditation Scheme for Conformity Assessment (ASCA)—which is transitioning from a pilot to full-fledged program as a means to facilitate companies’ reliance on certain standards to streamline premarket reviews.
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