Medical Device Makers

What arrives

Section 524B: FD&C Act section 524B, 21 U.S.C. 360n-2. A cyber device submission includes a postmarket vulnerability plan and a software bill of materials.; Source
The premarket guidance: FDA final guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, February 2026, including section 524B recommendations.; Source
The QMSR: Quality Management System Regulation, 21 CFR Part 820, incorporating ISO 13485 by reference. Effective February 2, 2026.; Source
The postmarket guidance: FDA final guidance, Postmarket Management of Cybersecurity in Medical Devices, December 27, 2016. Managing vulnerabilities in marketed and distributed devices.; Source