ELIMINATION OF UP TO 1,500 510(k) SUBMISSIONS PER YEAR PROJECTED THROUGH MORE EXEMPTIONS AND 510(k) "SUPPLEMENTS," FDA SAYS IN REENGINEERING PLAN
This article was originally published in The Gray Sheet
FDA's 510(k) reengineering proposals could eliminate up to 1,500 submissions annually by exempting additional devices from premarket requirements and creating 510(k) "supplements," the agency predicts.
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