FDA is proposing to selectively update the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This draft guidance provides updates to address the new requirements introduced by Section 524B of the FD&C Act regarding the cybersecurity of medical devices. It outlines who is required to comply with the section, the devices subject to it, and the documentation recommendations for premarket submissions. Additionally, FDA provides recommendations regarding premarket submissions for changes to cyber devices that had been previously authorized by FDA through 510(k), De Novo, HDE, PDP and PMA submission pathways. This draft guidance also discusses FDA’s review of whether there is a reasonable assurance that the device and related systems are cybersecure for marketing authorizations submitted for cyber devices.
FDA is proposing to add Section VII. to the current final version of Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&C Act. The Premarket Cybersecurity Guidance, in its current form, remains the Agency’s current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.
View the guidance and submit comments by May 13th here.
