Quality & Compliance: Reporting Manufacturing and Design Changes to Combination Product Marketing Applications

| 01 February 2010

This article, the sixth and final in a series on US Food and Drug Administration (FDA) regulation of combination products, covers reporting of postapproval (and postclearance) manufacturing and design changes to marketing applications (and notifications). Reporting change is the most complex of the combination product downstream issues.1 It involves determining when a change must be reported, when it can be implemented and the content of reports describing the change to be submitted to the agency. Drugs, biologics and medical devices have distinct rules about what constitutes a minor, moderate or major change, and different kinds of approval are required for manufacturers to effect these changes. How to apply these rules when different medical product types are combined is a complex problem. That a combination product can be formed in at least three ways and the resultant combination product types may be filed in single or multiple marketing applications further complicate the matter. The large number of possibilities makes it difficult to establish specific rules or algorithms to aid in decision making for reporting. Therefore, this article discusses only general approaches to reporting manufacturing and design changes to combination product marketing applications.


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