FDA’s Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Catapult’s regulatory round-up – March 2024)
The FDA has developed a draft guidance to propose select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (hereafter referred to as the “Premarket Cybersecurity Guidance”). FDA is proposing to add a Section VII. to the Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to be needed to support obligations under section 524B of the FD&C Act.
Published on the 2nd of April 2024 in Catapult’s regulatory round-up for March 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA’s Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Catapult’s regulatory round-up – March 2024). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12mix





