C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 878—GENERAL AND PLASTIC SURGERY DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 878.3500

Polytetrafluoroethylene with carbon fibers composite implant material

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(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

(b) Classification. Class II.

Notes of Decisions
Cited in 4 cases, 1993–1996 · leading case: Hoyt v. Vitek, Inc., 894 P.2d 1225 (Or. Ct. App. 1995).
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Hoyt v. Vitek, Inc., 894 P.2d 1225 (Or. Ct. App. 1995). · cites it 2× “” 21 CFR § 878.3500 . That classification permits a device to be marketed under the “general controls” applicable to all devices — including registration, labeling, good manufacturing practices and compliance with misbranding provisions — until the FDA establishes specific…”
Lamontagne v. EI Du Pont De Nemours & Co., 834 F. Supp. 576 (D. Conn. 1993). “23872 (June 24, 1988); 21 C.F.R. § 878.3500 (1992). It is therefore clear that the FDA has established specific regulations with respect to Proplast implant material made with PTFE.”
Anguiano v. E.I. Du Pont de Nemours & Co., 44 F.3d 806 (9th Cir. 1995). “3695 , and PTFE with carbon fibers composite implant material, 21 C.F.R. § 878.3500 . 2 As identification provisions, these regulations do not “relate to the safety or effectiveness of the device,” 21 U.”
Kealoha v. E.I. du Pont de Nemours & Co., 82 F.3d 894 (9th Cir. 1996). “3695 , and PTFE with carbon fibers composite implant material, 21 C.F.R. § 878.3500 . As identification provisions, these regulations do not “relate to the safety or effectiveness of the device,” 21 U.”
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