FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices.

Additionally, FDA's decisions to terminate completed recalls — that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls — were frequently not made within its prescribed time frames.

Finally, FDA did not document its justification for terminating recalls. If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. To aid its oversight of the medical device recall process, FDA should routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency's basis for terminating individual recalls. HHS agreed with GAO's recommendations.

Recommendation

To enhance FDA's oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, the Commissioner of FDA should create a program to routinely and systematically assess medical device recall information, and use this information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. This assessment should be designed, at a minimum, to identify trends in the numbers and types of recalls, devices most frequently being recalled, and underlying causes of recalls.

Agency Affected: Department of Health and Human Services: Food and Drug Administration

Status: In process

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

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