FDA Draft Guidance on Product Changes and the 510(K)

摘要

While the decision of when to file a new 510(k) on a changed product that has a previously cleared 510(k) by the same company is left to the manufacturer, the 2011 draft guidance underscores FDA's expectations for such changes. The company must maintain a good review process for each change, and then make a good faith well-documented effort to make the determination whether or not to file as a result of the most current change. The process should be defined, documented, and implemented in such a way that designated company personnel can readily, conscientiously, and consistently apply the analysis. Company personnel or others with a similar background must be able to defend the analysis to a representative of FDA (or in a court of law). Such a defense may be required months, if not years, later. The documentation and rationale must be presented in sufficient detail to allow others to provide such an explanation and defense.