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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR878.3530]
See Related Information on Silicone inflatable breast prosthesis. in CDRH databases



TITLE 21--FOOD AND DRUGS
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

Sec. 878.3530 Silicone inflatable breast prosthesis.

(a)Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(b)Classification. Class III.

(c)Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 17, 1999, for any silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before November 17, 1999, been found to be substantially equivalent to a silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone inflatable breast prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999]

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