Information for industry

Information for industry

• De Novo guidance updates:
• Final guidance - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Describes the FDA’s consideration of uncertainty when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence, and outlines a rigorous, methodical approach for the consideration of uncertainty when assessing the benefits and risks of a medical device and for determining when it may be appropriate to shift some data collection from the premarket to the postmarket phase. On October 16, 2019, FDA will host a webinar for stakeholders interested in learning more about this final guidance. (August 29, 2019)
• FDA also updated the guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, which describes the principal factors, including uncertainty of benefits and risks, the FDA considers when making benefit-risk determinations for certain premarket decisions. Appendices B and C of this guidance are updated with a revised Benefit-Risk Determination Worksheet that incorporates the same factors for benefit-risk determinations described in the guidance. The revised worksheet provides structure to guide and organize the benefit-risk factors and to support consistent decision-making. (August 29, 2019)
• Final guidance - Acceptance Review for De Novo Classification Requests - To explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This guidance also includes a De Novo Acceptance Checklist and a Recommended Content Checklist. (September 6, 2019)
• FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. Nominations received on or before October 29, 2019 will be given first consideration.
• Reminder: FDA is requesting nominations for voting members to serve on the Blood Products Advisory Committee. Nominations received on or before October 21, 2019 will be given first consideration.