CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR888]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 888 ORTHOPEDIC DEVICES

Subpart B - Diagnostic Devices

Sec. 888.1100 Arthroscope.

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]

Sec. 888.1240 AC-powered dynamometer.

(a) Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]

Sec. 888.1250 Nonpowered dynamometer.

(a) Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

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

Sec. 888.1500 Goniometer.

(a) Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.

(b) Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:

(i) The performance standard under part 898 of this chapter, and

(ii) The guidance entitled "Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables." This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

[65 FR 19319, Apr. 11, 2000]

Sec. 888.1520 Nonpowered goniometer.

(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

(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 § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

Sec. 888.1600 Bone indentation device.

(a) Identification. A bone indentation device is a device that measures resistance to indentation in bone.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation.

(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Performance testing must demonstrate:

(i) The sterility of the patient-contacting components of the device; and

(ii) Validation of reprocessing instructions for any reusable components of the device.

(6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.

(7) Software verification, validation, and hazard analysis must be performed.

(8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

(9) Labeling must include:

(i) Instructions for use;

(ii) Validated methods and instructions for reprocessing of any reusable components;

(iii) A shelf life for any sterile components;

(iv) Information regarding limitations of the clinical significance of the device output; and

(v) A detailed summary of the accuracy and precision of the device.

[88 FR 755, Jan. 5, 2023]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l , 371.
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.