---
kind: "section"
citation: "21 C.F.R. § 876.2050"
title: "21"
number: "876.2050"
heading: "Prostate lesion documentation system."
url: "https://uscodex.org/cfr/21/876.2050"
---

# §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.

## Notes

### Amendments

[80 FR 72900, Nov. 23, 2015]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[80 FR 72900, Nov. 23, 2015]