On December 29, 2022, the Consolidated Appropriations Act, 2023 (“Omnibus”) was signed into law. Section 3305 of the Omnibus — “Ensuring Cybersecurity of Medical Devices” — amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices (section 3305). The Omnibus states that the amendments to the FD&C Act shall take effect 90 days after the enactment of this Act, on March 29, 2023.
To mark the FDA cyber team’s 10-year anniversary, here is an infographic showing some of the ways they have contributed to patient safety over the past decade.
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September 26, 2023 – The FDA issued the final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions.
May 1, 2023 – The FDA has launched its third video: Tips for Health Care Facilities: Cybersecurity…
