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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR874.5900]
See Related Information on External upper esophageal sphincter compression device. in CDRH databases



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

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart F--Therapeutic Devices

Sec. 874.5900 External upper esophageal sphincter compression device.

(a) Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.

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

(1) The patient contacting components must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and

(ii) Shelf life testing.

(3) The technical specifications must include pressure measurement accuracy to characterize device performance.

(4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include the following:

(i) Appropriate warnings and precautions,

(ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events,

(iii) Detailed instructions on how to fit the device to the patient, and

(iv) Instructions for reprocessing of any reusable components.

(6) Patient labeling must be provided and must include:

(i) Relevant warnings, precautions, and adverse effects/complications,

(ii) Information on how to correctly wear the device,

(iii) The potential risks and benefits associated with the use of the device,

(iv) Alternative treatments, and

(v) Reprocessing instructions.

[80 FR 46194, Aug. 4, 2015]

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