FDA Issues Guidance on Distinguishing Device Recalls From Enhancements

October 15, 2014—The US Food and Drug Administration (FDA) has issued a guidance document for industry and FDA staff that addresses distinguishing medical device recalls from medical device enhancements.

This guidance applies to medical devices regulated by the Center for Devices and Radiological Health (CDRH), whether or not they require or are exempt from premarket review. The document defines and provides examples of key terms: Recall, Correction, Removal, Violation or Violative, Device Enhancement Stock Recovery, Market Withdrawal, and Routine Servicing. The document also addresses recall identification and differentiating violative devices from nonviolative devices.

According to the FDA, this guidance is intended to: (1) clarify when a change to a device constitutes a medical device recall; (2) distinguish those instances from device enhancements that do not meet the definition of a medical device recall; and (3) clarify reporting requirements under the Code of Federal Regulations (CFR), 21 CFR part 806.

The FDA stated that correctly categorizing a change to a device as a recall or an enhancement impacts the applicability and nature of industry responsibilities and FDA oversight. Clearly distinguishing medical device recalls from enhancements will assist the FDA and industry in assessing when 21 CFR part 7, subpart C, should be followed. Additionally, this guidance seeks to address concerns that companies may have about making enhancements.

This guidance is organized in a question-and-answer format, providing responses to questions that the FDA believes are helpful in properly distinguishing medical device recalls from medical device enhancements.

According to the document, the FDA defines a device recall by regulation as a company’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 (eg, seizure, under 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 FDA.

The FDA noted that 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 company on its own initiative or in response to a formal request from the FDA, and mandatory recalls ordered by the FDA under section 518 of the FD&C Act and 21 CFR part 810.1. Typically, the medical device recall process under 21 CFR part 7, subpart C is initiated and coordinated by the company. Subsequently, the recall gets classified, monitored, and terminated by FDA district offices and the CDRH.

According to the FDA, the recall process establishes a mechanism for companies that produce and market medical devices to take timely action to correct or remove violative devices. When a company’s recall process is operating effectively, the company identifies a device defect or failure, determines if a recall is appropriate, and initiates the recall process.

However, the agency noted that companies may have trouble identifying whether a change to a device meets the definition of a recall, the appropriate scope of a recall, and when FDA should be notified of a recall. All of these issues can result in inconsistent interpretation of regulations by industry members, uncertainty in companies’ regulatory responsibility, and delays between the times that a device defect or failure is identified and the time that the public is notified.

The agency advised that CDRH recognizes that continuous improvement activities, as part of an effective quality system, often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient. When new iterations of a device involve changes to device design, for example, it does not necessarily mean that the existing device should be recalled.