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FDA issues draft 510(k) device modification guidance

04 August 2011

Medical Device Alert

On Wednesday, 27 July 2011, the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance addressing the types of device modifications that require the submission of a new premarket notification (510(k)). The draft guidance, titled Draft Guidance for Industry and FDA Staff – 510(k) Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (Draft Guidance), provides a framework for manufacturers to use when determining whether a change to a 510(k)-cleared device necessitates a new 510(k) submission, as well as examples of device modifications that illustrate the guiding principles. If finalized, this Draft Guidance would supersede the earlier guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, issued 10 January 1997 (1997 Guidance).



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