Medical Devices 2011 - The FDA's New Draft Guidance on Medical Device Change(s) and the 510(k)

This training on FDA's new Draft Guidance will discuss how companies can best document their decision when a new 510(k) filing is warranted. It will assist in the implementation of formal methods with documented, and defensible rationale; which will also prepare industry for further 510(k) changes in the future.

The FDA has published a New Draft Guidance Document, "510(k) Device

Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", on July 27, 2011, that shows how companies are to perform meaningful, results driven 510(k) / change analysis activities. However, companies are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis.

This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning. It will expand this tool into training, marketing, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Regular use of these few simple but powerful tools in a Product Risk Management File and Report template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.