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GUIDANCE DOCUMENT

Distinguishing Medical Device Recalls from Medical Device Enhancements Guidance for Industry and Food and Drug Administration Staff October 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0114
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA defines a device recall by regulation as a firm's removal or correction of a marketed device that the Agency considers to be in violation of the laws that it administers and against which the agency would initiate legal action, e.g., seizure. 21 CFR 7.3(g). The key factor in distinguishing a medical device recall from an enhancement is the existence of a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 360h] or associated regulations enforced by the Agency.

Defects or performance failures of marketed medical devices can pose serious risks to public health. The recall process serves both to correct device defects and to notify users of potential risks and steps to minimize the impact of device failure or malfunction. Medical device recalls include voluntary recalls (covered by 21 CFR part 7, subpart C), either initiated by a firm on its own initiative or in response to a formal request from FDA, and mandatory recalls ordered by FDA under section 518 of the FD&C Act and 21 CFR part 810. Typically, the medical device recall process under 21 CFR part 7, subpart C is initiated and coordinated by the firm. Subsequently the recall gets classified, monitored, and terminated by FDA district offices and the Center for Devices and Radiological Health (CDRH).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2013-D-0114.

 
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