Both stakeholders say that AI should support clinical workflows and that clinicians should maintain decision-making authority.
FD&C Act 1938
According to the regulator, ExThera Medical sent its Seraph 100 blood filters to a hospital for emergency/compassionate use without first obtaining permission.
Enforcement
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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.
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.
The three letters point to an enforcement posture toward manufacturers marketing biologics derived from human placentas and umbilical cords.
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.