‘Paradoxical’ FDA Recalls Report Credits Industry Collaboration For Improved Quality, But Uncovers Troubling Data About Older Devices
• By Shawn M. Schmitt
Medical devices on the market for more than five years are recalled more often than younger ones, according to a recent FDA 10-year retrospective report on corrections and removals. “There is an intuitive appeal to the argument that devices that come to the market in an early point in their lifespan – say, the first year – are more likely to be subject to recalls, but that is simply not true,” CDRH Office of Compliance Director Steven Silverman says. Other notable report findings: troubles with components and software are the leading causes for most recalls; problems with AEDs, ventilators and infusion pumps have triggered an increase in high-risk class I recalls; and domestic manufacturers recall products at a much greater volume than those outside the United States.
FDA’s device center is scratching its head after an internal report concluded that the bulk of products recalled since 2010 are medical devices that have been sold to consumers for more than half a decade.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
