Experts: FDA May Be Recalling Devices With No Defects

November 13, 2009
If certain recent medical device recalls signal that the FDA has a new recall policy, it could have a devastating impact on product innovation, industry attorneys and experts say.

The agency has recently required devicemakers to recall products not because of safety issues or complaints but because the manufacturer improved the product and the FDA wanted all older versions recalled, according to device attorneys.

“I can’t imagine anyplace in the regulations that says something like that,” Dan O’Leary, president of Ombu Enterprises, said at a recent FDAnews webinar. FDA rules state that a device recall can only be requested when a device poses a safety risk to consumers, he said.
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