FDA Recalls Guidance Seeks To Allay Manufacturer Anxieties About Device Safety Enhancements
This article was originally published in The Gray Sheet
Executive Summary
A new draft guidance tries to reassure manufacturers that they can make changes to improve a device's performance or safety without fear that FDA will necessarily require a recall. But early reactions suggest industry may not be happy with at least one component of the document.
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‘Paradoxical’ FDA Recalls Report Credits Industry Collaboration For Improved Quality, But Uncovers Troubling Data About Older Devices
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.
Device Makers To FDA: Recall The Recalls Draft Guidance
The draft guidance is an attempt by FDA to reassure companies that they can make an enhancement to a marketed device without worrying that the action will be perceived as a recall. But the effort appears to have increased, rather than alleviated, industry anxieties.
Regulatory News In Brief
FDA draft guidance explains the difference between recalls and product enhancements. Proposed rule on non-U.S. studies. More regulatory news.