A second look at 510(k) changes

Overview: 

The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters.  In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not.  The decision has to be made by the manufacturer, subject to review by the FDA inspector.  This talk will provide quality and regulatory personnel the means to help to the company make the right decision and document it fully, before the change goes through.

Why should you Attend: 

Failure to file a 510(k) for a change to a product which has already been cleared under 510(k) is one of the more frequent complaints in 483's and in warning letters.  The result of this finding is the requirement to file a 510(k) for a product that is on the market, and usually, to file a 510(k) and have the change cleared before the product can be marketed with the change.  In general, FDA will not insist on recalling product with the change already in the market unless they decide there is a safety issue, but even so, this means disruption of the manufacturing (already producing the changed product) and marketing for the product.  The best approach is to understand what FDA means by a "significant change" and document completely the reasons why you believe the change does not warrant a filing. 

Areas Covered in the Session:

• Background: the regulation
• Guidance and FDA expectations
• Concrete examples
• Analysis (consecutive changes)and checklist
• Documentation

Who Will Benefit:

• QA and RA specialists
• QA and RA managers