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: 21CFR876.2050]

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. 876.2050 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]