On June 16, 2016, FDA published Factors to Consider Regarding Benefit – Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions – Draft Guidance for Industry and Food and Drug Administration Staff for comments which are due within 90 days of publication in the Federal Register.
This draft guidance, when finalized, is intended to harmonize FDA’s approach to weighing benefits and risks for medical device (post market) product availability, compliance, and enforcement decisions with FDA’s benefit-risk framework for assessing medical device marketing and investigational device exemption (IDE) applications. This draft guidance is intended to complement, not supplant, FDA’s “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” dated March 28, 2012.1
The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may consider the benefit-risk factors during, for example, evaluation of device shortage situations, selection of the appropriate regulatory engagement mechanism following an inspection during which regulatory non-compliance was observed, evaluation of recalls, and consideration of petitions for variance from those sections of the Quality System (QS) regulation (21 CFR part 820) for which there were inspectional observations during a Premarket Approval (PMA) pre-approval inspection.
(Premarket submission review decisions, such as premarket notification [510(k)] substantial equivalence determinations, de novo classification, and PMA, Humanitarian Device Exemption [HDE] or IDE application approval decisions, are beyond the scope of this draft guidance.)
When prioritizing compliance and enforcement efforts to maximize medical device quality and patient safety, FDA may assess the extent of benefit of a device by considering factors such as type of benefit(s), magnitude of benefit(s), likelihood of patients experiencing one or more benefits, duration of effects, patient preference on benefit, benefit factors for healthcare professionals or caregivers, and medical necessity.
FDA may also assess the risk that a medical device will cause patient direct or indirect harm by considering factors such as medical device-related deaths and serious injuries, medical device-related non-serious adverse events, medical device-related events without reported harm, and duration of harm to patient.
FDA has provided the following reference information as Appendices in the draft guidance:
Appendix A discusses the intersection of this draft guidance with ISO 14971: Medical devices – Application of risk management to medical devices. ISO 14971 provides medical device manufacturers with a framework to systematically manage the risks to people, property and the environment associated with the use of medical devices. FDA notes that they expect that manufacturers will incorporate postmarket data into their device risk management process, including new risks and changes to existing risks identified after the device is on the market. FDA also notes that documentation of risk management decisions by manufacturers (as discussed in the draft guidance) may help to streamline these decisions for both FDA and manufacturers, produce outcomes for patients that deliver the most benefit for the least amount of risk, and provide a reasonable assurance of safety and effectiveness.
Appendix B provides a worksheet for benefit assessments. Some potential sources of benefit information include literature, prior premarket submissions, clinical studies, registries, patient input, knowledgeable clinicians, and risk management documentation voluntarily supplied by the manufacturer.
Appendix C provides a worksheet for risk assessments. Some potential sources of risk information include medical device reports (MDRs), inspection reports, literature, prior premarket submissions, clinical studies, registries, patient input, knowledgeable clinicians and risk management documentation voluntarily supplied by the manufacturer.
Appendix D provides a worksheet for assessing potential decisions based on the benefit-risk assessment outcome.
U.S. Food & Drug Administration. (2012, March 28). Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. Retrieved September 06, 2016, from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf