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- FDA issues updated guidance on the regulation of digital health technologies
FDA issues updated guidance on the regulation of digital health technologies
November 25, 2019, Westlaw Journal Medical Devices
August 18, 2020, Covington Digital Health
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software. The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which ...
October 8, 2019, Covington Digital Health
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ...
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 ...