|
|
| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR878] |
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. 878.3250 External facial fracture fixation appliance.
|
|
(a) Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]
|
|
|
Sec. 878.3300 Surgical mesh.
|
|
(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
(b) Classification. Class II.
|
|
|
Sec. 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
|
|
(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.
|
|
|
Sec. 878.3510 Carbon dioxide gas controlled tissue expander.
|
|
(a) Identification. A carbon dioxide gas controlled tissue expander is a prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. The device utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of patient-contacting components of the device.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Cycle testing of expander showing that there are no leaks or tears after repeated cycling;
(ii) Mechanical assessment of implanted carbon dioxide (CO2) canister including high impact testing;
(iii) Leak testing of expander showing that device does not leak CO2;
(iv) Assessment of gas permeability during expansion and after full expansion; and
(v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing).
(5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user.
(9) Physician labeling must include:
(i) The operating parameters, name, and model number of the indicated external dosage controller;
(ii) Information on how the device operates and the typical course of treatment;
(iii) Information on the population for which the device has been demonstrated to be effective;
(iv) A detailed summary of the device technical parameters; and
(v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander.
(10) Patient labeling must include:
(i) Warnings, precautions, and contraindications, and adverse events/complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-operative care instructions; and
(v) Alternative treatments.
(11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted.
[87 FR 6421, Feb. 4, 2022]
|
|
|
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]
|
|
|
Sec. 878.3540 Silicone gel-filled breast prosthesis.
|
|
(a) Identification - (1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast.
(2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell 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.
(3) Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.
(b) Classification. Class III.
(c) Date premarket approval application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or before July 9, 1991 for any silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 9, 1991 been found to be substantially equivalent to a silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed in commercial distribution.
[53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991]
|
|
|
Sec. 878.3550 Chin prosthesis.
|
|
(a) Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
(b) Classification. Class II.
|
|
|
Sec. 878.3590 Ear prosthesis.
|
|
(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
(b) Classification. Class II.
|
|
|
Sec. 878.3610 Esophageal prosthesis.
|
|
(a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
(b) Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."
[65 FR 17145, Mar. 31, 2000]
|
|
|
Sec. 878.3680 Nose prosthesis.
|
|
(a) Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.
(b) Classification. Class II.
|
|
|
Sec. 878.3720 Tracheal prosthesis.
|
|
(a) Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
(b) Classification. Class II. The special control for this device is FDA's "Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses."
[65 FR 17146, Mar. 31, 2000]
|
|
|
Sec. 878.3750 External prosthesis adhesive.
|
|
(a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
|
|
|
Sec. 878.3800 External aesthetic restoration prosthesis.
|
|
(a) Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
|
|
|
Sec. 878.3900 Inflatable extremity splint.
|
|
(a) Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]
|
|
|
Sec. 878.3910 Noninflatable extremity splint.
|
|
(a) Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]
|
|
|
Sec. 878.3925 Plastic surgery kit and accessories.
|
|
(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, 2000]
|
|
|
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 53 FR 23872, June 24, 1988, unless otherwise noted.
|
|
