This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
FDA's New Draft Guidance on Medical Device Changes and the 510(k)
7 September 2011, Wilmington, United States
Introduction
Venue
online training webinar
online training webinar, 1000 N West Street,, Suite 1200, Wilmington, 19801, United States
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Organised by
global compliance panel
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