FDA has issued guidance on applying human factors and usability engineering to medical devices, focusing on user interface design, use-related risk management, critical tasks and human factors validation testing.

FDA has issued draft guidance on biocompatibility testing of medical devices under the ASCA Program, covering recognized standards, laboratory accreditation, test methods and premarket submission content.

FDA issues final guidance on cybersecurity in medical devices, outlining QMS, premarket documentation, and Section 524B requirements for manufacturers.