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Code of Federal Regulations Title 21. Food and Drugs § 21.872.3930 Bone grafting material

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

(b) Classification.

(1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document:  Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)

(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.

(c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.872.3930 Bone grafting material - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-872-3930/

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