This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011.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).

Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format . Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.

Why you should attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Now a new draft guidance document from the FDA is designed to add more consistency to this process: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. In addition, growing high-profile field problems indicate that change control and its effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional results. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the recommended fixes and incorporation of current Agency thinking are not rocket-science, but require the implementation of formal methods with documented, and defensible, rationale.

Areas Covered in the Session:
FDA Device Clearance / Changes in Direction
The New Draft Guidance on Product Changes and Filing a New 510(k)
The New Guidance on Manufacturing, Labeling, Tech/Performance and/or+B41 Materials Changes
Tracking / Evaluating Changes and the "Tipping Point"
Expanding FDA's K97-1 and "Decision Tree" Model / Matrix
Resolving a "Wrong" Decision
Who Will Benefit:
Senior management in Devices and Combo Products
QA
RA
R&D
Engineering
Production
Operations
Consultants

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884