The U.S. FDA has developed a draft guidance to propose select updates to its Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions document.
The 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 generally be necessary to support obligations under section 524B of the FD&C Act.
In its current form, the guidance remains the agency’s current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II. of the draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.
Industry stakeholders are able to leave a public comment under the docket number FDA-2021-D-1158. To have the comment considered by the agency, it must be submitted by May 13, 2024.
