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- FDA Reauthorization Act of 2017 Key Provisions Related to Medical Devices
FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices
September 20, 2017, Covington Alert
On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee Amendments, and the Generic Drug User Fee Amendments. The agency’s existing authority to collect user fees under these programs ends on September 30, 2017. Under FDARA, the user fee programs have been reauthorized through fiscal year 2022. FDARA also includes important substantive amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”).
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
November 2017, Journal of Medical Device Regulation
December 6, 2016, Covington Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...