Regulatory Focus™ > News Articles > Implementation of Medical Device Recall Authority Sought by FDA

Implementation of Medical Device Recall Authority Sought by FDA

Posted 10 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced on 10 February that it is seeking to implement its medical device recall authority under § 518(e) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Chapter 21, Section 810 of the Code of Federal Regulations (CFR).

Section 518(e) allows FDA to order manufacturers to cease distribution of a device and notify health professionals if FDA finds a "reasonable probability that the device intended for human use would cause serious adverse health reactions or death."

This authority is carried out through a three-step process which includes FDA notifying the manufacturer of its intent to order a recall, an opportunity for the manufacturer to contest or amend FDA's recall order, and the issuance or non-issuance of a recall order by FDA.

The authority would be used to ensure that all marketed devices are safe and effective, allow detection of any serious problems with medical devices and allow for the removal of dangerous devices from the market.

FDA noted that no comments were received on its 16 November notice of the impending notice. The implementation now goes to the Office of Management and Budget for Review.

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