to increase the apparent size of object detail.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in Part 807, Subpart E of this chapter. The device also is exempt from the current good manufacturing practice regulations 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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

§ 886.5916 Rigid gas permeable contact lens.

(a) Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

§ 886.5918 Rigid gas permeable contact lens solution.

(a) Identification. A rigid gas permeable contact lens solution is a device intended to clean, disinfect, wet, or store a rigid gas permeable contact lens (§ 886.5916).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

§ 886.5925 Soft (hydrophilic) contact lens. (a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer ma

strained cemented or uncemented prosthesis.

888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

888.3340 Hip joint metal/composite semiconstrained cemented prosthesis. 888.3350 Hip joint metal/polymer semiconstrained cemented prosthesis. 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

semi-con

polymer/metal/polymer

strained cemented prosthesis.

888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis. 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.

888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis. 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis. 888.3680 Shoulder joint glenoid (hemi

shoulder) metallic cemented prosthesis. 888.3690 Shoulder joint humeral (hemishoulder) metallic uncemented prosthesis.

888.3720 Toe joint polymer constrained prosthesis.

888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

888.3750 Wrist joint carpal lunate polymer prosthesis.

Sec.

888.3760 Wrist joint carpal scaphoid polymer prosthesis.

888.3770 Wrist joint carpal trapezium poly

mer prosthesis.

888.3780 Wrist joint polymer constrained prosthesis.

888.3790 Wrist joint metal constrained cemented prosthesis.

888.3800 Wrist joint metal/polymer semiconstrained cemented prosthesis. 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

Subpart E-Surgical Devices

888.4150 Calipers for clinical use.

888.4200 Cement dispenser.

888.4210 Cement mixer for clinical use. 888.4220 Cement monomer vapor evacuator. 888.4230

Cement ventilation tube. 888.4300 Depth gauge for clinical use. 888.4540 Orthopedic manual surgical in

strument.

888.4580 Sonic surgical instrument and accessories/attachments.

888.4600 Protractor for clinical use. 888.4800 Template for clinical use. 888.5850 Nonpowered orthopedic traction apparatus and accessories.

888.5890 Noninvasive traction component. 888.5940 Cast component.

888.5980 Manual cast application and removal instrument.

AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371).

SOURCE: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

(c) To avoid duplicative listings, an orthopedic device that has two or more types of uses (e.g., used both as a diagnostic device and as a surgical device) is listed in one subpart only.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.

§ 888.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section

501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

§ 888.5 Resurfacing technique.

Because of resurfacing techniques, certain joint prostheses require far less bone resection than other devices intended to repair or replace the same joint. The amount of bone resection may or may not affect the safety and effectiveness of the implantation of the prosthesis. When a resurfacing technique is used, the name of the prosthesis includes this information.

§ 888.6 Degree of constraint.

Certain joint prostheses provide more constraint of joint movement than others. FDA believes that the

degree of constraint is an important factor affecting the safety and effectiveness of orthopedic prostheses. FDA is defining the following standard terms for categorizing the degree of constraint.

(a) A "constrained" joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one component linked together or affined.

(b) A "semi-constrained" joint prosthesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no acrossthe-joint linkage.

(c) A "non-constrained" joint prosthesis is used for partial or total joint replacement and restricts minimally prosthesis movement in one or more planes. Its components have no acrossthe-joint linkage.

§ 888.9 Limitations of exemptions from section 510(k) of the act.

FDA's decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; e.g., the device is intended for a different medi

cal purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or

(b) The modified device operates using a different fundamental scientific technology than that in use in the device before May 28, 1976; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology.

[53 FR 52953, Dec. 29, 1988]

(b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807.

Subpart C-[Reserved]

Subpart D-Prosthetic Devices

§ 888.3000 Bone cap.

(a) Identification. A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.

(b) Classification. Class II.

§ 888.3010 Bone fixation cerclage.

(a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and

that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

(b) Classification. Class II.

§ 888.3015 Bone heterograft.

(a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 888.3.

§ 888.3020 Intramedullary fixation rod.

(a) Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.