FD&C Act 1938
-
Epic Systems, Oracle Health submit recommendations for HHS AI guidance
Both stakeholders say that AI should support clinical workflows and that clinicians should maintain decision-making authority.
-
FDA warns medical device maker about clinical trial, premarket violations
According to the regulator, ExThera Medical sent its Seraph 100 blood filters to a hospital for emergency/compassionate use without first obtaining permission.
-
FDA issues warning letters to four companies for sale of HIV self-collection blood tests
The federal regulator contends the four biologics firms lack appropriate testing and marketing authorization.
-
FDA signals less regulation for wearable devices, AI providing non-medical information
According to new guidance, certain devices and software that track metrics such as heart rate and activity level will require less rigorous pre-market reviewal.
-
FDA turns focus on biologics in spate of warning letters
The three letters point to an enforcement posture toward manufacturers marketing biologics derived from human placentas and umbilical cords.
-
Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.