Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA ... Read More
The FDA approved marketing of a prescription smartphone app to help patients with substance abuse issues. The app, reSET, from Pear Therapeutics, is the first approved mobile medical application for treatment of substance use disorder. Read More
Manufacturers of microneedling instruments that go beyond removal of dead skin cells should apply to the FDA for the first-ever marketing authorization of their products as medical devices, the agency says in draft guidance. Read More
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More
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