Distinguishing Medical Device Recalls from Medical Device Enhancements
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0114.