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FDA's New Draft Guidance on Medical Device Changes

The FDA expects corporations to conduct meaningful, results-driven 510(k) and change evaluation activities. Companies are held totally answerable for figuring out when a brand new 510(k) submission is necessary. The FDA has released a brand new draft steering doc to bring more consistency to this process, titled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device," dated July 27, 2011. Additionally, fda compliance consultants -profile area points have highlighted that change control and its impression on regulatory evaluate processes may not be absolutely leveraging the potential of present risk management tools, which must be an integral part of such an analysis. The FDA is making a concerted effort to strengthen the 510(k) process in the united states and reevaluate "grandfathered" products. Current methods are perceived as not delivering the product security or efficacy that was initially promised. For most corporations, the recommended solutions aren't overly advanced but require the implementation of formal strategies with documented and justifiable reasoning.

Areas Covered within the Session:

FDA Device Clearance and Changes in Direction
The New Draft Guidance on Product Changes and Filing a New 510(k)
The New Guidance on Manufacturing, Labeling, Technology/Performance, and Materials Changes
Tracking and Evaluating Changes and Identifying the "Tipping Point"
FDA's K97-1 and "Decision Tree" Model and Matrix

Resolving a Decision That Was Deemed Incorrect

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Pub: 30 Mar 2024 09:39 UTC
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