21 C.F.R. § 3.4

Designated agency component

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(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 effectiveness with regard to the combination product as a whole, the agency will assign the combination product to the agency component with the most expertise related to the most significant safety and effectiveness questions presented by the combination product.

(c) The designation of one agency component as having primary jurisdiction for the premarket review and regulation of a combination product does not preclude consultations by that component with other agency components or, in appropriate cases, the requirement by FDA of separate applications.

[56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005]

Notes of Decisions

Cited in 3 cases, 2012–2014 · leading case: Prevor v. United States Food & Drug Admin., 895 F. Supp. 2d 90 (D.D.C. 2012).

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Prevor v. United States Food & Drug Admin., 895 F. Supp. 2d 90 (D.D.C. 2012). · cites it 3× “§ 353 (g)(1); 21 C.F.R. § 3.4 . To determine which agency component will regulate a given combination product, FDA assesses a product’s primary mode of action (“PMOA”).”

Miller Ex Rel. Est. of Kelly v. Mylan Inc., 741 F.3d 674 (6th Cir. 2014). · cites it 2× “21 C.F.R. § 3.4 . The “primary mode of action” determination involves the technical application of the definition provided in 21 C.”

Prevor v. United States Food & Drug Admin., 67 F. Supp. 3d 125 (D.D.C. 2014). “*133 21 C.F.R. § 3.4 (b). According to FDA, if the Agency were to classify RSDL today, it likely would find that RSDL’s primary mode of action cannot be determined with reasonable certainty, and it may well have assigned it to the ODER for possible regulation as a drug.”

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