Fda Current Guidance On 510k Device Modifications PowerPoint PPT Presentations

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"

The Jungle, Upton Sinclair, 1906 ... Observation of animals. Pathological examination of animals ... All manufacturers must list w FDA all devices they ...

Alternative Approaches to FDA Approval for Drug and Device Firms San Diego Regulatory Affairs Network November 28, 2006 Michael A. Swit Vice President

Chapter 16 The Food and Drug Administration * * * * * * * * * * * * * * Software If part of a device, generally must meet same minimum standards as the device.

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"