Draft Guidance Outlines FDA’s Expectations for Meeting FDORA Submission Mandates for Cyber Devices
March 14, 2024 at 01:32 PM EST
The FDA has proposed additional recommendations for meeting the agency’s cybersecurity requirements for medical devices and for providing documentation of cybersecurity protections in premarket submissions.
On March 12, the FDA released a draft guidance document, “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act,” which the agency said... Read More
