FDA Panel Picks, More IVD 510(k)s Coming, EU AI Act Advances, and More

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In this week’s Pathways Picks: One FDA panel complains about product codes as a device shortage reporting tool, and another weighs in on pulse oximeter performance; FDA says it plans to transition a large number of IVDs from PMAs to 510(k)s; EU ministers advance the AI Act closer to passage; updated MDR/IVDR data; medtech groups meet with the EPA on impending rule; IMDRF issues draft software guide; and more medtech policy updates.

FDA Panel Picks

Two agency advisory panels met in recent days:

Product codes complicate shortage reporting. FDA convened an advisory panel Tuesday to provide input on its proposed list (506J Device List) of 284 product codes that could be subject to mandatory disclosures by manufacturers of potential supply disruptions in the context of a public health emergency. But there was major barrier to the discussion: the codes themselves. Product codes are the primary way in which device categories are organized within FDA’s regulatory framework and the means by which Congress required FDA to compile the 506J Device List under 2022 legislation. But, experts from FDA’s General Hospital and Personal Use Devices Panel lamented, product codes are too broad, with one code encompassing various related supplies where some might be critical and vulnerable to shortages during emergencies and others might not. Mandating companies to send reports on all items within a product code could lead to unnecessary distractions and complications, panelists warned. “There might be a necessity to have some sub-codes,” said Jason Dominitz, MD, executive director of the National Gastroenterology and Hepatology Program (Seattle), echoing many of his panelist colleagues.

FDA officials said they were stuck with the product codes under the statute, but they understood the frustration. “We realize the difficulties and challenges in providing recommendations by product code,” Tammy Beckham, associate director of CDRH’s Resilient Supply Chain Program, said in concluding the meeting. Industry representatives at the meeting urged the panel and FDA to take a pragmatic approach to the list. “There are going to be trade-offs here,” said Mark Leahey, CEO of the Medical Device Manufacturers Association said. “There should be need to have versus nice to have.” Public comments on FDA’s proposed 506J list are due February 15.


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