Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct a defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device failure or malfunction. Medical device recalls include voluntary recalls, either initiated by a firm on its own initiative or in response to a formal request from FDA (covered by 21 CFR part 7, subpart C), and mandatory recalls ordered by FDA under section 518 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
The recall process establishes a mechanism for firms that produce and market medical devices to take timely action to correct violative devices or remove them from the marketplace when correction or removal is necessary to protect the public health. When a firm’s recall process is operating effectively, the firm identifies a device defect or failure, determines a recall is appropriate, and triggers the initiation of the recall process. However, firms 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 firms, uncertainty in firms’ regulatory responsibility, and delays between the time a device defect or failure is identified and the time the public is notified.
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, it does not necessarily mean that the existing device has been recalled. This draft guidance is intended to clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the definition of a medical device recall, and to identify the associated regulatory reporting requirements for each. Correctly categorizing a change to a device as a recall or product enhancement impacts the applicability and nature of industry responsibilities and FDA oversight. See 21 CFR part 7 subpart C. Clearly distinguishing medical device recalls from product enhancements will assist FDA and firms in assessing when 21 CFR Part 7 Subpart C should be followed. Additionally, this draft guidance seeks to address concerns that firms may have about making product enhancements.
Reports of corrections and removals under 21 CFR part 806 may be required for corrections and removals regardless of whether the implemented change meets the definition of a medical device recall. See sections V and VI for more information about reporting requirements under 21 CFR part 806 for recalls and product enhancements, respectively. This guidance does not address when changes to marketed devices trigger new premarket submissions.
This guidance is organized in a question-and-answer format, providing responses to questions that FDA believes are helpful in properly identifying medical device recalls. Throughout this guidance the term “you” refers to manufacturers as defined in 21 CFR 806.2(g). This draft guidance does not address radiation defects or failures to comply with radiation safety performance standards contained in 21 CFR Parts 1020 to 1050. Document issued on: February 22, 2013.
Submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.