U.S. – Federal Drug Administration Updates Enforcement Policy for Face Masks and Respirators

Vol. 1161 | 08 Jun 2020

The U.S. Federal Drug Administration (FDA) has issued additional guidance to allow an expanded availability of face masks for the general public and respirators for health care personnel (HCP). This guidance has an indefinite timeframe based upon the length of the COVID-19 situation.

Background

COVID-19 has placed an enormous strain on the supply of equipment designed to slow the spread of the disease. In an effort to lessen this burden, the FDA has released a series of documents including the original March 25, 2020, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” and the revised version on April 2, 2020. This revised edition included two key items: the inclusion of face shields and the allowance for alternatives when FDA-cleared or National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators are in limited supply. On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) letter to manufacturers of non-NIOSH-approved disposable filtering facepiece respirators (FFR) that allowed products that met the requirements of another country, limited to Australia, Brazil, Europe, Japan, Korea, and Mexico, to be placed on the market under the EUA. On April 3, 2020, another EUA was issued that allowed non-NIOSH-approved respirators made in China to be placed on the market under certain conditions.

Following this revised April 2020 guidance and expanded EUA, the FDA and Centers for Disease Control (CDC) began receiving complaints and performing testing on respirators entering the market and found a significant number of respirators failing to provide the protection they claimed.  On May 7, 2020, the FDA issued a revised EUA for Chinese-manufactured respirators and subsequently removed a large number of previously authorized products from Appendix A. Therefore, additional clarification has been provided in the May 26, 2020, revision of “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).” The guidance now states that greater oversight will be given by the FDA for respirators that are not FDA cleared or authorized.

The May 2020 Guidance document can be found at: https://www.fda.gov/media/136449/download

Key Takeaways from May 2020 Guidance Document

Alternatives When FDA-Cleared or NIOSH-Approved N95 Respirators are Not Available

The FDA believes that whenever possible FDA-cleared or NIOSH Approved N95 respirators only should be used. When not available FDA-authorized respirators should be used.  This clarifies the fact that only FDA-cleared, FDA-authorized, or NIOSH-approved devices shall be used as a respirator.  Items that do not fall under one of these categories may be used as a face mask if the device meets the applicable EUA.

Additionally, the FDA has noted the importance of performing personalized fit testing, the critical nature of a properly fitting respirator, and the potential difficulty of a respirator with only ear loops to meet this requirement.

EUAs for Face Masks Intended for a Medical Purpose, Surgical Masks and N95 Respirators

The FDA has multiple EUAs covering these topics including the below:

• NIOSH approved FFR - https://www.fda.gov/media/135763/download
• Imported Non-NIOSH Approved FFRS from other than china - https://www.fda.gov/media/136403/download
• Non-NIOSH Approved FFRs manufactured in China - https://www.fda.gov/media/136664/download
• EUA Source Control for General public and HCP face masks - https://www.fda.gov/media/137121/download

Face Masks, Face Shields, and N95 Respirators Not Intended for a Medical Purpose

• Non-medical devices are not covered under this guidance. To not be considered medical item must NOT:
  1. Be labeled or otherwise intended for use by health care personnel (HCP)
  2. Be labeled or otherwise for use in a health care facility or environment
  3. Include any drugs, biologics, or anti-microbial/anti-viral agents

Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection

For the duration of this emergency a 510(K) submission is not required and the FDA currently believes such devices would not create such an undue risk where:

• The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFR) and includes a list of the body contacting materials (which does not include any drugs or biologics);
• The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas; and
• The product is not intended for any use that would create an undue risk in light of the public health emergency, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims

Face Shields Intended for a Medical Purpose

Under the advice for HCP to follow CDC rules regarding personal protective equipment (PPE) during the outbreak, the FDA does not object to face shields for either the HCP or general public provided the device doesn’t create an undue risk without Registration and Listing requirements in 21 CFR 807, Quality System Regulation.

Requirements in 21 CFR Part 820, Reports of Corrections and Removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. The FDA currently believes such devices would not create such an undue risk where:

• The product includes labeling that accurately describes the product as a face shield and includes a list of the body contacting materials (which does not include any drugs, or biologics);
• The face shield does not contain any materials that will cause flammability, or the product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);
• The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, or for radiation protection.

Surgical Mask intended to Provide Liquid Barrier Protection

The FDA does not intend to object to the distribution and use of surgical masks without compliance with the following regulatory requirements where the surgical mask does not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81, Registration and Listing requirements in 21 CFR 807, Quality System Regulation requirements in 21 CFR 820, Reports of Corrections and Removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:

• The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
• The product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);
• The product includes labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include any drugs or biologics); and
• The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims.

For more information, please contact Jason Allen (jason.allen@intertek.com)