FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the intent of providing clarity for FDA staff and the medical device industry regarding the benefit and risk factors the FDA may consider when prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. These risk-benefit factors may be considered when device manufacturers evaluate appropriate responses to non-conforming product or regulatory compliance issues, including voluntary recall or market withdrawal, and apply to both diagnostic and therapeutic medical devices. The FDA is currently accepting public comments on the draft guidance document.

In its draft guidance, the FDA sets out specific factors for the assessment of medical device benefits. These factors include the types of benefits and their impact on patient health and clinical management; the magnitude of the benefits, including the degree to which patients experience the benefit of the device; the likelihood of patients experiencing one or more benefits, specifically the likelihood that the medical device will effectively treat or diagnose the patient’s disease or condition; the duration of effects; the value patients place on the use of the device; the benefit that healthcare providers experience in caring for their patients; and medical necessity.

In addition to assessment of benefits, the FDA also sets out specific factors it may consider when assessing medical device risks. These factors include the severity of the risk, including death and serious injury, non-serious adverse events and events without reported harm, and the likelihood of risk; specifically the likelihood that the medical device will exhibit a specific failure or defect, and the proportion of the intended population treated with the device that would be expected to experience a harmful event if exposed to a nonconforming device. The FDA will also consider whether the nonconforming product has been distributed and if so, how many nonconforming devices are on the market, the duration of exposure to the population, false positive and false negative results, and patient tolerance of risks. Risk factors for healthcare professionals or providers may be considered when the risk may have an adverse impact on the caregiver.

In addition to assessing benefit and risk factors, the FDA may consider additional factors, including uncertainty, mitigation, detectability, the type of failure, the scope of the device at issue and its application industry wide, the impact on patients, the nature of the violation, and the manufacturers compliance history.

While this guidance document does not establish legally enforceable responsibilities and does not preclude the FDA from taking regulatory or other action in response to legal or regulatory violations, it does provide guidance on the FDA’s current thinking and provides clear recommendations to medical device manufacturers. Understanding how the FDA considers these factors will allow medical device manufacturers and their legal counsel to be better prepared when dealing with the FDA and to better anticipate FDA actions on medical device product availability, compliance, and enforcement issues.

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