Who should file: the sponsor of:

Any combination product the sponsor believes is not covered by an intercenter agreement; or

Any product where the agency component with primary jurisdiction is unclear or in dispute.

When to file: a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice. Sponsors are encouraged to file a request for designation as soon as there is sufficient information for the agency to make a determination.

What to file: an original and two copies of the request for designation must be filed. The request for designation must not exceed 15 pages, including attachments, and must set forth:

The identity of the sponsor, including company name and address, establishment registration number, company contact person and telephone number.

A description of the product, including:

Classification, name of the product and all component products, if applicable;

Common, generic, or usual name of the product and all component products;

Proprietary name of the product;

Identification of any component of the product that already has received premarket approval, is marketed as not being subject to premarket approval, or has received an investigational exemption, the identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product.

Chemical, physical, or biological composition;

Status and brief reports of the results of developmental work, including animal testing;

Description of the manufacturing processes, including the sources of all components;

Proposed use or indications;

Description of all known modes of action, the sponsor's identification of the single mode of action that provides the most important therapeutic action of the product, and the basis for that determination.

Schedule and duration of use;

Dose and route of administration of drug or biologic;

Description of related products, including the regulatory status of those related products; and

Any other relevant information.

The sponsor's recommendation as to which agency component should have primary jurisdiction based on the mode of action that provides the most important therapeutic action of the combination product. If the sponsor cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product, the sponsor's recommendation must be based on the assignment algorithm set forth in § 3.4(b) and an assessment of the assignment of other combination products the sponsor wishes FDA to consider during the assignment of its combination product.

Where to file: all communications pursuant to this subpart shall be addressed to the attention of the product jurisdiction officer. Such a request, in its mailing cover should be plainly marked “Request for Designation.” Concurrent submissions of electronic copies of Requests for Designation may be addressed to combination@fda.gov.