FDA Device Chief Says Approval ‘Loophole’ Needs to Be Closed

The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.

House Democrats introduced legislation this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a “loophole” that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.