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: 21CFR876.1450]

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 B - Diagnostic Devices

Sec. 876.1450 Esophageal tissue characterization system.

(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

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

(1) All patient contacting components of the device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

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

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

[86 FR 68399, Dec. 2, 2021]