‘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.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
