Update: Importation and Distribution of Face Masks and Respirators During the COVID-19 Pandemic

To help address the urgent public health concerns caused by shortages of these products, FDA has issued a new Enforcement Policy found here. This new policy allows for the importation and/or distribution of certain non-FDA-approved masks and respirators when specified criteria are satisfied. This new policy also allows for certain modifications to currently FDA approved masks and respirators. This Policy takes effect immediately and is intended to remain in effect only during the COVID-19 public health emergency.

In addition to the updated FDA policy, CBP has also updated some previous guidance for importing PPE and other medical devices during the pandemic. The FDA and CBP Policy updates are summarized below.

Updated FDA Policy

There are many types of face masks and respirators that protect against a range of health hazards. When intended for a medical purpose[1] — whether for a healthcare professional, a patient, or general public use — those products are regulated by FDA as medical devices.

The various types of face masks and respirators regulated by FDA as medical devices include, for example, surgical masks with and without antimicrobial/antiviral agents, surgical respirators, and N95 respirators.[2].

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

So long as no undue risk is presented, FDA does not intend to object to the distribution and use of this type of mask (not including respirators) intended for a medical purpose but that does not comply with FDA’s premarket notification (“510(k)”) requirements, registration and listing, the quality system regulation, Unique Device Identification requirements, and certain reporting requirements.

The product labeling for such devices must:

1. accurately describe the product as a face mask (as opposed to a surgical mask or respirator) and include a list of body contacting materials (that does not include any drugs or biologics);
2. make recommendations that would reduce sufficiently the risk of use (e.g., recommending against use in a clinical setting where infection risk level through inhalation exposure is high); and
3. instruct that the product is not intended for use for antiviral protection or related uses for infection prevention or reduction and does not include particulate filtration claims.

Surgical Masks Intended to Provide Liquid Barrier Protection

So long as no undue risk is presented, FDA also does not intend to object to the distribution and use of this type of mask intended for a medical purpose but that fails to comply with FDA’s “510(k)” requirements.

In order to fall within this category, the surgical mask must meet the following conditions:

1. it must meet fluid resistance testing consistent with applicable FDA-recognized liquid barrier performance standards (ASTM F1862);
2. it must meet Class 1 or II flammability requirements per 16 CFR 1610 (unless labeling recommends against use in presence of high-intensity heat source or flammable gas)
3. the labeling must accurately describe the product as a surgical mask and include a list of the body contact materials (that does not include any drugs or biologics); and
4. the mask is not intended for use for any use that would create an undue risk (e.g., the labeling does not include uses for antiviral protection or related uses or for infection prevention or reduction and does not include particulate filtration claims.

EUAs for Masks and Respirators

As we have reported recently, FDA has issued Emergency Use Authorizations (EUAs) for certain N95 FFRs (Filtering Facepiece Respirators), including NIOSH-approved disposables. These EUAs were issued pursuant to FDA’s Letter of Authorization dated March 2, 2020. Notably, under a new Letter of Authorization dated March 24, 2020, FDA has also now issued a Letter of Authorization for the importation of certain non-NIOSH-approved disposable FFRs, which sets out its scope and instructions for requesting an EUA.

To increase needed supply for these PPEs, FDA has also expressed interest in hearing from manufacturers of masks and respirators that do not fall within the scope of either of its March 2 or 24 Letters of Authorization, and also manufacturers in non-device sectors who have the capacity to supply the market.

To this end, FDA has advised interested manufacturers to contact CDRH-COVID19-SurgicalMasks@fda.hhs.gov. It has agreed to expeditiously review the information provided to determine whether a device is eligible for authorization under an EUA.

For manufacturers of masks and respirators whose products are not currently marketed in the US, FDA asks that the following information be provided: general information, including contact, device, model number, marketing authorization in the current country or region (if applicable); a copy of the product labeling; whether the manufacturer has documented compliance with either the FDA’s Quality System regulations, ISO 13485, and/or an equivalent quality system; and a description of testing conducted on the device, including performance standards met.

FDA also encourages manufacturers who have not previously been engaged in medical device manufacturing, including manufacturers in other sectors, but that have capabilities to increase supply to contact the Agency and provide a description of their proposed approach.

EUAs for Reprocessing FFRs

In addition, FDA has announced that it is interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate and other FFRs to facilitate marketing authorization through an EUA for these reprocessed devices. FDA recommends that interested firms contact FDA at CDRH-COVID19-SurgicalMasks@fda.hhs.gov. Such contact should include information such as a description of the process for disinfection/reprocessing controls; validation of bioburden reduction/disinfection; description of chain of custody and safeguards to prevent inadvertent exposure; material compatibility; filtration performance; fit test data; and a copy of the proposed reprocessed device labeling. For a more detailed discussion of the information recommended to be provided to FDA, see pp. 7-8 of Policy.

Updated CBP Guidance

On March 27, 2020, CBP issued updated guidance on instructions for filling entry on PPE and other medical devices during the COVID-19 pandemic. The information updates its previous message #42124872 issued on March 23, 2020. The message is copied, in part, below; the key clarifications involve:

For Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA) and Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

• At the time of entry, under the Intended Use Codes provided in this message for entry, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
• Updated product codes for diagnostic tests and masks.
• FDA notes it may request additional information to confirm admissibility of products.

The message also provides additional information related to updated FDA guidance and contacts for questions at FDA and to receive a review of EUAs or expedited premarket clearance of PPE or other medical devices. More details are here.

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

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 Use the Product Classification and Product Code Builder

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

Not required to submit a 510(k) during the Covid-19 Public Health Emergency, but registration and listing are still required.

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 prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81, 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 F18627Standard 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 Use the Product Classification and Product Code Builder

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.

N95s under EUA

Subject to registration and listing requirements.  Please transmit under the corresponding affirmations of compliance if available (e.g. DEV, DFE, LST).

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

ACE Transmission Requirements for N95s under EUA:
 
Program Code:            DEV
Processing Code:        NED
Intended Use Code:   940.000 if the product is listed on Appendix B of the EUA
          081.001 if not listed on Appendix B of the EUA
Product Code:             80N—JZ or 80O—RW (with antimicrobial or antiviral agent)

Use the Product Classification and Product Code Builder

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.

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[1] As used in this Guidance, “intended for a medical purpose” means that the device is intended for use in the “diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” This is consistent with the definition of “device” in the federal Food, Drug, and Cosmetic Act. As discussed in our prior Alert, when a face mask or respirator is marketed for general, non-medical purposes, such as use in construction and other industrial applications, they are not regulated by FDA as they are not intended for medical use.

[2] A complete list of the categories of masks and respirators regulated by FDA as medical devices can be found at p. 3 of this Guidance.