FD&C Act 1938
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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.
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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.
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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.
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Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.