The Distinguishing Medical Device Recalls from Medical Device Enhancements guidance addresses questions and inconsistencies that arise when making changes to a marketed device. When determining whether a change to a device is classified as a recall or enhancement, you should always carefully review all appropriate regulations. The FDA defines a medical device recall 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.”
Marketed medical devices with defects can cause serious risks to the public. The recall process is in place to properly correct device defects and to notify the public of potential risks. The medical device recall process is usually initiated and coordinated by the company. Once the recall is initiated it gets classified, monitored, and terminated by FDA and the CDRH. If there is uncertainty in the recall process there are serious delays between when the recall is identified and reported and the time in which the public is alerted of the problem.
Companies may have trouble identifying whether a change to a device meets the definition of a recall or an enhancement. New versions of a device often involve changes to device design. This does not necessarily mean that the existing device should be recalled. The changes may be considered to be a medical device enhancement and would follow a different course of action from a medical device recall.
Properly defining a change to a device as a recall or an enhancement is an important step to protecting public health. These definitions also impact the industry responsibilities and appropriate FDA oversight. For further information read the full guidance here.