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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 2020.

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, 2020]
[CITE: 21CFR886.5310]
See Related Information on Intranasal electrostimulation device for dry eye symptoms. 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 886 -- OPHTHALMIC DEVICES

Subpart F - Therapeutic Devices

Sec. 886.5310 Intranasal electrostimulation device for dry eye symptoms.

(a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.

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

(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.

(2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(3) Patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.

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

(6) Training for the proper use of the device must be provided.

(7) Physician and patient labeling must include:

(i) Summaries of electrical stimulation parameters;

(ii) Instructions on how to correctly use and maintain the device;

(iii) Instructions and explanations of all user-interface components;

(iv) Information related to electromagnetic compatibility classification;

(v) Instructions on how to clean the device; and

(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.

[83 FR 52975, Oct. 19, 2018]

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