Medical Device Link.

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

FDA recommends that a sponsor request designation formally (by RFD) in cases in which a product is not covered by the intercenter agreements or any precedent jurisdictional decision, and where the agency center with primary jurisdiction is unclear or in dispute. Formal RFDs should not exceed 15 pages and should be filed prior to any application for premarket review, whether an application for premarket approval (PMA) or a required investigational notice. All relevant sponsor information must be supplied, along with a thorough description of the product that should include the following information (21 CFR 3.7(c)):

1. The identity of the sponsor, including essential contact information.
2. A product description, including:
   • The product classification, name of the product, and all component products.
   • The common, generic, or usual name of the product and all component products.
   • The proprietary name of the product.
   • Identification of components of the product that have already received PMA, are not subject to PMA, or have an investigational exemption.
   • The chemical, physical, or biological composition of the product.
   • The status of developmental work, including animal testing, and brief reports of results.
   • A description of manufacturing processes, including the sources of all components.
   • Proposed uses or indications.
   • A description of all known modes of action, the sponsor's identification of the primary mode of action, and the basis for that determination.
   • The schedule and duration of use.
   • The dose and route of administration of the drug or biologic.
   • A description of related products and their regulatory status.
   • Additional relevant information.
3. The sponsor's recommendation as to which agency center should have primary jurisdiction, with an accompanying statement of reasons.

An RFD is reviewed for completeness within five working days of receipt by FDA. If deemed complete, the agency informs the sponsor that the request has been accepted for filing. The jurisdiction officer must issue a letter of designation within 60 days of this filing date. If the sponsor disagrees with the designation, it may submit a written request for reconsideration within 15 days of receipt of the designation letter. Alternatively, the sponsor may take its request to the FDA ombudsman for final resolution.

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