C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 3—PRODUCT JURISDICTION › Subpart A—Assignment of Agency Component for Review of Premarket Applications

21 C.F.R. § 3.3

Scope

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This section applies to:

(a) Any combination product, or

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