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: 21CFR880.6260]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G - General Hospital and Personal Use Miscellaneous Devices

Sec. 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.

(a) Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.

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

(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.

(2) The FDA guidance document entitled: "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies." See § 880.1(e) for information on obtaining a copy of this guidance document.

[72 FR 36362, July 3, 2007]