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8820.198, with respect to complaint files.

(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988)

lenses worn by a patient to correct refractive errors.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994)

8886.5810 Ophthalmic prism reader.

(a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

(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]

$886.5844 Prescription spectacle lens.

(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994)

$886.5820 Closed-circuit television

reading system. (a) Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.

(b) Classification. Class I. The ACpowered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

8886.5850 Sunglasses (nonprescrip

tion). (a) Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

(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 8 886.9.

(52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000)

8886.5840 Magnifying spectacles.

(a) Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994) 8886.5842 Spectacle frame.

(a) Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle

$ 886.5870 Low-vision telescope.

(a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.

(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)

source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

(b) Classification. Class I. The ACpowered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The battery-powered device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of 8 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994)

$ 886.5900 Electronic vision aid.

(a) Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994)

$ 886.5910 Image intensification vision

aid. (a) Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.

(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 8820.198, with respect to complaint files.

8886.5916 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. (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(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 a device described in paragraph (b)(2) of this section may be commercially distributed. See $ 886.3. (52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994)

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

$ 886.5918 Rigid gas permeable contact

lens care products. (a) Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

[blocks in formation]

8886.5933 [Reserved]

(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

PART 888-ORTHOPEDIC DEVICES

Subpart A-General Provisions

[62 FR 30987, June 6, 1997)

Sec. 888.1 Scope. 888.3 Effective dates of requirement for pre

market approval. 888.5 Resurfacing technique. 888.6 Degree of constraint. 888.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B-Diagnostic Devices

8886.5925 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 materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

(b) Classification. (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(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 a device described in paragraph (b)(2) of this section may be commercially distributed. See 8886.3.

888.1100 Arthroscope. 888.1240 AC-powered dynamometer. 888.1250 Nonpowered dynamometer. 888.1500 Goniometer. 888.1520 Nonpowered goniometer.

Subpart C [Reserved]

Subpart D-Prosthetic Devices

(52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994)

8 886.5928 Soft (hydrophilic) contact

lens care products. (a) Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

888.3000 Bone cap. 888.3010 Bone fixation cerclage. 888.3015 Bone heterograft. 888.3020 Intramedullary fixation rod. 888.3025 Passive tendon prosthesis. 888.3027 Polymethylmethacrylate (PMMA)

bone cement. 888.3030 Single/multiple component metallic

bone fixation appliances and accessories. 888.3040 Smooth or threaded metallic bone

fixation fastener. 888.3050 Spinal interlaminal fixation ortho

sis. 888.3060 Spinal intervertebral body fixation

orthosis. 888.3070 Pedicle screw spinal system. 888.3100 Ankle joint metal/composite semi

constrained cemented prosthesis. 888.3110 Ankle joint metal/polymer semi

constrained cemented prosthesis. 888.3120 Ankle joint metal/polymer non-con

strained cemented prosthesis. 888.3150 Elbow joint metal/polymer con

strained cemented prosthesis. 888.3160 Elbow joint metal/polymer semi

constrained cemented prosthesis. 888.3170 Elbow joint radial (hemi-elbow)

polymer prosthesis. 888.3180 Elbow joint humeral (hemi-elbow)

metallic uncemented prosthesis. 888.3200 Finger joint metal/metal con

strained uncemented prosthesis. 888.3210 Finger joint metal/metal con

strained cemented prosthesis.

[62 FR 30988, June 6, 1997)

888.3220 Finger joint metal/polymer con

strained cemented prosthesis. 888.3230 Finger joint polymer constrained

prosthesis. 888.3300 Hip joint metal constrained ce

mented or uncemented prosthesis. 888.3310 Hip joint metal/polymer con

strained cemented or uncemented pros

thesis. 888.3320 Hip joint metal/metal semi-con

strained, with a cemented acetabular

component, prosthesis. 888.3330 Hip joint metal/metal semi-con

strained, with an uncemented acetabular

component, prosthesis. 888.3340 Hip joint metal/composite semi

constrained cemented prosthesis. 888.3350 Hip joint metal/polymer semi-con

strained cemented prosthesis. 888.3353 Hip joint metal/ceramic/polymer

semi-constrained cemented or nonporous

uncemented prosthesis. 888.3358 Hip joint metal/polymer/metal semi-constrained

porous-coated uncemented prosthesis. 888.3360 Hip joint femoral (hemi-hip) metal

lic cemented or uncemented prosthesis. 888.3370 Hip joint (hemi-hip) acetabular

metal cemented prosthesis. 888.3380 Hip joint femoral (hemi-hip) trun

nion-bearing metal/polyacetal cemented

prosthesis. 888.3390 Hip joint femoral (hemi-hip) metal/

polymer cemented or uncemented pros

thesis. 888.3400 Hip joint femoral (hemi-hip) metal

lic resurfacing prosthesis. 888.3410 Hip joint metal/polymer semi-con

strained resurfacing cemented pros

thesis. 888.3480 Knee joint femorotibial metallic

constrained cemented prosthesis. 888.3490 Knee joint femorotibial metal/com

posite non-constrained cemented pros

thesis. 888.3500 Knee joint femorotibial metal/com

posite semi-constrained cemented pros

thesis. 888.3510 Knee joint femorotibial metal/poly

mer constrained cemented prosthesis. 888.3520 Knee joint femorotibial metal/poly

mer non-constrained cemented pros

thesis. 888.3530 Knee joint femorotibial metal/poly

mer semi-constrained cemented pros

thesis. 888.3540 Knee joint patellofemoral polymer/

metal semi-constrained cemented pro

thesis. 888.3550 Knee joint patellofemorotibial

polymer/metal/metal constrained ce

mented prosthesis. 888.3560 Knee joint patellofemorotibial

polymer/metal/polymer semi-constrained

cemented prosthesis. 888.3570 Knee joint femoral (hemi-knee) me

tallic uncemented prosthesis.

888.3580 Knee joint patellar (hemi-knee) me

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

tallic 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. 888.3670 Shoulder joint metal/polymer/metal

nonconstrained or semi-constrained po

rous-coated uncemented prosthesis. 888.3680 Shoulder joint glenoid (hemi-shoul

der) metallic cemented prosthesis. 888.3690 Shoulder joint humeral (hemi

shoulder) metallic uncemented pros

thesis. 888.3720 Toe joint polymer constrained pros

thesis. 888.3730 Toe joint phalangeal (hemi-toe)

polymer prosthesis. 888.3750 Wrist joint carpal lunate polymer

prosthesis. 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 ce

mented prosthesis. 888.3800 Wrist joint metal/polymer semi

constrained cemented prosthesis. 888.3810 Wrist joint ulnar (hemi-wrist) poly

mer 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 instru

ment. 888.4580 Sonic surgical instrument and ac

cessories/attachments. 888.4600 Protractor for clinical use. 888.4800 Template for clinical use. 888.5850 Nonpowered orthopedic traction ap

paratus and accessories. 888.5890 Noninvasive traction component. 888.5940 Cast component. 888.5960 Cast removal instrument. 888.5980 Manual cast application and re

moval instrument.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

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

a

Subpart A-General Provisions $888.1 Scope.

(a) This part sets forth the classification of orthopedic devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by $ 807.87.

(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.

tive 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.

an

$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 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 effec

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