FDA Update – COVID-19

Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency

This week, the FDA released a guidance outlining their enforcement policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency.  This includes general use face masks for the general public and particulate filtering face-piece respirators (i.e. N95 respirators) for health care professionals.  The FDA is taking steps to expand the availability of face masks and respirators during the current public health emergency.

Face masks and filtering face piece respirators that are marketed to the general public for general, non-medical purposes, such as use in construction or other industrial applications do not require FDA device marketing authorization and all other requirements of the FD&C Act DO NOT apply to their manufacturers, importers, and distributors.

As per the most recent CSMS, at the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code.  Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.  Below is a list of products and the appropriate product codes that are currently authorized by an EUA:

• Diagnostic tests:  83QKP, 83QKO, 83QJR    
• Masks/Respirators: 80NZJ

Face Masks and N95 Respirators not intended for a medical purpose are not required to be transmitted to the FDA and can be disclaimed.

When considering whether these products are intended for a medical purpose, among other considerations, the FDA will look at whether:

1. they are labeled or otherwise intended for use by a health care professional;
2. they are labeled or otherwise for use in a health care facility or environment; and
3. they 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 are not required to transmit registration, listing, or 5109k) during the COVID-19 public health emergency.

To ensure the availability of equipment that might offer some benefit to health care providers and the general public during the COVID-19 outbreak, for the duration of the public health emergency, the FDA does not intend to object to the distribution and use of face masks (not including respirators) that are intended for a medical purpose (whether used by medical personnel or the general public), without compliance with the following regulatory requirements where the face masks does not create an undue risk in the 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 or corrections and removals in 21 CFR Part 806, and
• Unique Device Identification requirements in 21 CFR Part 830.

The FDA currently believes such devices would not create an undue risk where:

• The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFD) and includes a list of the body contacting materials.
• The product includes labeling that makes recommendations that would reduce sufficiently the risk of use;
• The product is not intended for any use that would create an undue risk.

ACE Transmission Requirements for this type of face mask:

Program Code: DEV
Processing Code: NED
Intended Use Code: 081.006 Enforcement Discretion
Product Code: 80Q—KR

Please see FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) for a full list of ACE transmission requirements, including mandatory/conditional/optional AofCs.

Surgical Masks intended to provide liquid barrier protection are not required to submit a 510(k) during the COVID-19 public health emergency.

Surgical masks are class II devices that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials and are tested for flammability and biocompatibility.  FDA does not intend to object where, for the duration of the declared public health emergency, surgical masks are distributed and used without public health emergency, surgical masks are distributed and used without prior submission of a premarket notification, and the surgical masks do not create an undue risk in light of the public health emergency.  The product meets fluid resistance testing (Liquid barrier performance) consistent with standard ASTM F18627 Standard Test Method for Resistance of Medical Face Masks to Penetration by synthetic blood.

The FDA currently believes such devices would not create an undue risk where:

• The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F18627 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, 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.

ACE Transmission Requirements for surgical masks:

Program Code: DEV

Processing Code: NED

Intended Use Code: 081.001 Standard Import of a foreign manufactured device

081.006 Enforcement Discretion

Product Code: 80F—XX

For the latest information from the FDA regarding the Coronavirus, please refer to the FDA’s Coronavirus page.

If you have any specific questions regarding the how your devices could be affected by the FDA EUA and how to deal with the FDA under this Coronavirus situation, feel free to reach out to mdi for assistance via email at [email protected] RE: COV19