The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The.
FDA published guidance on cybersecurity requirements for certain device premarket submissions outlining implementation of new Section 524B of Federal Food, Drug, and Cosmetic Act FDCA. Manufacturers must meet cybersecurity requirements.
FDA published groundbreaking draft guidance concerning use of artificial intelligence machine learning in medical devices. FDA attempt to provide support for the development of safe and effective medical devices that use machine learning enabled device software functions
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in.
The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.