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The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Read More
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
The FDA issued final guidance recommending what information devicemakers should include in test report summaries, test protocols and complete rest reports for non-clinical bench performance testing for their premarket submissions. Read More
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed regulatory framework. Read More
A trade group representing hybrid drug- and device-makers is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The FDA issued a draft guidance and proposed order designed to ensure the safe and effective use of surgical staplers and staples for internal use. Read More