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Device Makers To FDA: Recall The Recalls Draft Guidance

The draft guidance is an attempt by FDA to reassure companies that they can make an enhancement to a marketed device without worrying that the action will be perceived as a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.

FDA’s draft guidance distinguishing between recalls and product enhancements was not well received by members of industry, who claim that the proposal requiring companies to submit “corrections and removals” reports for product enhancements would inappropriately insert recalls processes into pre-market review. AdvaMed and several individual device firms are calling for FDA to withdraw the guidance and issue a new one.

The draft guidance, issued in February, is an attempt by FDA to reassure companies that they can make an enhancement to a marketed device without worrying that the...

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