Title 21 CFR reference

This regulation relates to agency management and organization and has two purposes. The first is to implement section 503(g) of the act, as added by section 16 of the Safe Medical Devices Act of 1990 (Public Law 101-629) and amended by section 204 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250), by specifying how FDA will determine the organizational component within FDA designated to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of a drug and a device; a device and a biological; a biological and a drug; or a drug, a device and a biological. This determination will eliminate, in most cases, the need to receive approvals from more than one FDA component for such combination products. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for determining which agency component will have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. Nothing in this section prevents FDA from using any agency resources it deems necessary to ensure adequate…

Any filing with or review by the product jurisdiction officer stays the review clock or other established time periods for agency action for an application for marketing approval or required investigational notice during the pendency of the review by the product jurisdiction officer.

For the purpose of this part: Act(a) means the Federal Food, Drug, and Cosmetic Act. Agency component(b) means the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, or alternative organizational component of the agency. Applicant(c) means any person who submits or plans to submit an application to the Food and Drug Administration for premarket review. For purposes of this section, the terms “sponsor” and “applicant” have the same meaning. Biological product(d) has the meaning given the term in section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). Combination product(e) includes: (1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that…

This section applies to: (a) Any combination product, or (b) Any product where the agency component with primary jurisdiction is unclear or in dispute.

(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of: (1) A drug (other than a biological product), the agency component charged with premarket review of drugs shall have primary jurisdiction; (2) A device, the agency component charged with premarket review of devices shall have primary jurisdiction; (3) A biological product, the agency component charged with premarket review of biological products shall have primary jurisdiction. (b) In some situations, it is not possible to determine, with reasonable certainty, which one mode of action will provide a greater contribution than any other mode of action to the overall therapeutic effects of the combination product. In such a case, the agency will assign the combination product to the agency component that regulates other combination products that present similar questions of safety and effectiveness with regard to the combination product as a whole. When there are no other combination products that present similar questions of safety and…

Federal Register04(a)(1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have entered into agreements clarifying product jurisdictional issues. These guidance documents are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are entitled “Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;” “Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research;” “Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.” The availability of any amendments to these intercenter agreements will be announced by notice. (2) These guidance documents describe the allocation of responsibility for categories of products or specific products. These intercenter agreements, and any amendments thereto, are nonbinding determinations designed to provide useful guidance to the public. (3) The sponsor of a…

combination@fda.gov,The Office of Combination Products (Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,, e-mail: is the designated product jurisdiction officer. [68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006; 75 FR 13678, Mar. 23, 2010]

(a) Who should file: the sponsor of: (1) Any combination product the sponsor believes is not covered by an intercenter agreement; or (2) Any product where the agency component with primary jurisdiction is unclear or in dispute. (b) 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. (c) 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: (1) The identity of the sponsor, including company name and address, establishment registration number, company contact person and telephone number. (2) A description of the product, including: (i) Classification, name of the product and all component products, if applicable; (ii) Common, generic, or usual name of the product and all component products; (iii) Proprietary name of the product; (iv) Identification of any…

(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notified of the filing date. (b) Within 60 days of the filing date of a request for designation, the product jurisdiction officer will issue a letter of designation to the sponsor, with copies to the centers, specifying the agency component designated to have primary jurisdiction for the premarket review and regulation of the product at issue, and any consulting agency components. The product jurisdiction officer may request a meeting with the sponsor during the review period to discuss the request for designation. If the product jurisdiction officer has not issued a letter of designation within 60 days of the filing date of a request for designation, the sponsor's recommendation of the center with primary jurisdiction, in accordance with § 3.7(c)(3), shall become the designated agency component. (c) Request for reconsideration by sponsor: If the sponsor disagrees with the designation, it…

(a) The letter of designation constitutes an agency determination that is subject to change only as provided in paragraph (b) of this section. (b) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor, or without its consent to protect the public health or for other compelling reasons. A sponsor shall be given 30 days written notice of any proposed nonconsensual change in designated agency component. The sponsor may request an additional 30 days to submit written objections, not to exceed 15 pages, to the proposed change, and shall be granted, upon request, a timely meeting with the product jurisdiction officer and appropriate center officials. Within 30 days of receipt of the sponsor's written objections, the product jurisdiction officer shall issue to the sponsor, with copies to appropriate center officials, a written determination setting forth a statement of reasons for the proposed change in designated agency component. A nonconsensual change in the designated agency component requires the concurrence of the Principal Associate Commissioner. [56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]