Description

Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing

A series of minor changes or
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 should you 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. Growing high-profile field problems indicate that change control and it s 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 in the U.S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered in the Session: