FDA issues draft 510(k) device modification guidance

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the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance addressing the types of device modifications that require the submission of a new premarket notification (510(k)). The draft guidance, titled Draft Guidance for Industry and FDA Staff – 510(k) Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (Draft Guidance), provides a framework for manufacturers to use when determining whether a change to a 510(k)-cleared device necessitates a new 510(k) submission, as well as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 If finalized, this Draft Guidance would supersede the earlier guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, issued 10 January 1997 (1997 Guidance).

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