ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA rolls out a new draft guidance for predetermined change control plans, this time not just for AI; the agency signals active surveillance plans; Jeff Shuren attracts conflict-of-interest scrutiny; Medicare coverage and coding updates; new IVDR requirements proposed in the EU; and more.
Top Pick: PCCP Guide
An expanded guide to change control plans:
FDA published a draft guidance August 21 on “Predetermined Change Control Plans for Medical Devices.”
While the agency last year issued a draft guide on PCCPs for artificial intelligence/machine learning devices, this latest document explores the prospect of employing the novel modification mechanism to any type of device as part of a 510(k), PMA, or De Novo submission. In 2022, Congress gave FDA explicit authority to use PCCPs, which allow manufacturers to make certain types of modifications to a device over time, based on a plan vetted by FDA during an original marketing review, without having to go back to the FDA for authorization. Since 2020, FDA has incorporated PCCPs into authorizations for at least 35 devices, primarily including AI/ML-based devices and IVDs, according to an analysis posted by former FDA digital health official Brendan O’Leary August 20.
The draft guidance details expected PCCP procedures and provides 10 examples of applying the approach, including as a means to update gene variants detected by an IVD, change a sterilization method for a surgical suture, and add a new connected data source for a mobile app. It also cautions, though, that modifications that could introduce new risks are generally not appropriate for a PCCP. Comments on the draft are due November 20.
