CFR - Code of Federal Regulations Title 21

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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: 21CFR876]

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

PART 876 GASTROENTEROLOGY-UROLOGY DEVICES

Subpart C - Monitoring Devices

Sec. 876.2040 Enuresis alarm.

(a) Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.

(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 § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]

Sec. 876.2050 Prostate lesion documentation system.

(a) Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

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

(1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.

(2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.

(3) Appropriate software verification, validation, and hazard analysis must be performed.

(4) All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(5) Methods and instructions for reprocessing of any reusable components must be properly validated.

(6) The labeling must include specific information needed to ensure proper use of the device.

[80 FR 72900, Nov. 23, 2015]

Sec. 876.2100 Pressure ulcer management tool.

(a) Identification. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.

(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 § 876.9.

[86 FR 70735, Dec. 13, 2021]

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.