Draft Guidance for your comments
This draft guidance document provides clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. FDA believes that explaining the factors listed in this draft guidance document will improve the consistency and transparency in medical device decision making in the product availability, compliance and enforcement decisions.
When finalized, the guidance is intended to provide a framework for FDA and stakeholders that sets forth overarching benefit-risk principles. FDA may consider the types of benefit-risk factors described in this draft guidance—including reliable patient preference information from a representative sample—on a case-by-case basis when determining the appropriate actions to take. This draft guidance applies to both diagnostic and therapeutic medical devices subject to, and exempt from, premarket review. When prioritizing compliance and enforcement efforts to maximize medical device quality and patient safety, FDA may assess the extent of benefit of a device.
You should submit comments and suggestions regarding this draft document within 90 days (before September 14, 2016) of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Submit electronic comments to regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852
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