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The FDA issued a final rule on appealing CDRH’s significant decisions about medical devices, including procedures for submitting requests and timelines for the agency’s responses. Read More
The lawmakers noted that former FDA Commission Scott Gottlieb had voiced his disapproval for expanding conditional approval pathways to include human medical products. Read More
The firm was ordered to identify the affected devices and contact the manufacturer to obtain a service kit or schedule machines for upgrade, prioritizing devices used at home. Read More