FDA Issues Updated Final Guidance on Cybersecurity in Medical Devices
FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.
FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers
The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.