FDA’dan medikal araçların geri çağrılması hakkında taslak kılavuz (İng)


FDA issues draft guidance on Medical Device Recalls 

The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn’t need one, saying it recognizes that continuous improvement activities often have a favourable 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.

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 This draft guidance is intended to clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet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. (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 Additionally, this draft guidance seeks to address concerns that firms may have about making product enhancements.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. 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. 

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.