Requesting Designation

Originally Published MX May/June 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Sponsors of combination products with clearly definable parameters, such as those characterized or specifically listed in the intercenter agreements, can easily assess which FDA center will have primary jurisdiction and whether other centers could have collaborative or consultative roles in the application process. In cases in which the designation of primary jurisdiction is not clear, however, the sponsor must solicit FDA's assistance in making a determination of the regulatory path to follow.

Informal Requests

Informal requests for designation typically are made when a sponsor anticipates a possible debate over determination of the primary mode of action of the device and hopes to resolve the jurisdictional issue at the program level before a dispute arises. When sufficient product information is available, a manufacturer can contact the FDA's jurisdictional experts to try to expedite the process.

Formal Requests