The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a draft guidance to clarify when changes to an existing device will require the submission of a new 510(k) premarket notification. The issuance of the draft guidance fulfills one of the 25 action items outlined in CDRH’s January 2011 510(k) and Science Report Recommendations, part of the agency’s ongoing review of the device premarket review process. When finalized, this guidance document will supersede the agency’s 1997 guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device. While the draft guidance is not legally binding, it represents the FDA’s current thinking on the subject.
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