Importation of Masks, Hand Sanitizer, and Medical Gowns during COVID-19

Food and Drug Administration (FDA)

Updated May 1, 2020

March 24, 2020 – Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, there has been an increase in the importation of protective masks, hand sanitizer, and medical gowns to avoid exposure. Livingston has researched these products to determine if this merchandise would be regulated by the FDA, and if so, what would be required.

The World Customs Organization (WCO) has also provided trade with an HS Classification Reference for COVID-19 Medical Supplies that can be referenced for any tariff classifications related to high demand medical supplies.

U.S Customs and Border Protection services has published a notice, CSMS #42448725 on information for filing personal protective equipment and medical devices during COVID-19.

Masks

Emergency Use Authorization (EUA). The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures (MCM) needed during public health emergencies.

COVID-19 and the products used to counter it are personal protective equipment (PPE), diagnostic tests and other devices. This guidance is for testing as well as policies and will last only as long as the public health emergency.

There are three different categories of personal protective equipment.

1. Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.)
   • These items by nature are not indicated for medical use, will not be used in medical facilities, and are not labeled as protecting against COVID-19. No entry declaration is required for FDA
   • When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether:
     • They are labeled or otherwise intended for use by a health care professional;
     • They are labeled or otherwise for use in a health care facility or environment;
     • They include any drugs, biologics, or anti-microbial/anti-viral agents.
   • If any equipment is intended for a medical facility or is labeled as protecting against COVID-19, then it will be regulated by an EUA or other enforcement discretion policy guidance.

2. Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)
   • Firms who have applied for, and received approval for specific products under an EUA are entitled to reporting of reduced FDA information when reporting Intended Use Code 940.000 (Compassionate Use/Emergency Use) and an appropriate FDA product code specific to pre-approved product. Affirmations of compliance then become optional when using that intended use code.
     • Below is a list of products and certain product codes authorized by an EUA. A complete list of product codes may be found in corresponding enforcement policy guidance documents identified below.
       • Non-NIOSH-Approved Respirators: 80QKU
       • NIOSH-Approved Respirators
       • Face Masks (Non-Surgical)
       • Diagnostic Tests Kits
       • Ventilators
       • Face Shields
       • Respirator Decontamination Systems
       • Extracorporeal Blood Purification Devices
       • Infusion Pumps
       • Ventilators
       • Diaphragmatic Pacing Simulator Systems
   • A full list of Emergency Use Authorizations currently in place for the COVID-19 emergency is also available on FDA’s website.Please check this site regularly for current information on products authorized by an EUA
     • • The only IVD test kits authorized to be imported are products that have an Emergency Use Authorization (EUA). Approved EUAs are found here.

3. Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.
   • Importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, 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.
   • The following are specific products related to COVID-19, which reference applicable product codes and policy for those products:

• • • Telethermographic Systems
    • Remote Ophthalmic Assessment and Monitoring Devices
    • Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices
    • Infusion Pumps and Accessories
    • Digital Health Devices for Treating Psychiatric Disorders
    • Clinical Electronic Thermometers
    • Gowns, Other Apparel, and Gloves
    • Sterilizers, Disinfectant Devices and Air Purifiers
    • Face Masks and Respirators
    • Non-Invasive Remote Monitoring Devices
    • Ventilators and Accessories and Other Respiratory Devices
    • Diagnostic Tests
  • A full list of all guidance documents related to COVID-19 is also available on FDA’s website.

As indicated in FDA’s Consumer Update from 3/24/2020, there are currently no vaccines to prevent or drugs to treat COVID-19 approved by the FDA.

On March 20, 2020, the FDA alerted the American public that, at this time, the FDA has not authorized any test that is available to purchase for at-home testing for COVID-19.

Please check this site, as well as Information for Filing Personal Protective Equipment and Medical Devices During COVID-19, regularly for current information on these and other product areas

Hand Sanitizer

Hand Sanitizer is always considered a drug by FDA standards if it contains an active ingredient. Typically hand sanitizer contains alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride – which are all considered to be active ingredients.

1. The following information must be reported to FDA for products categorized as drugs:
   1. FDA Actual Manufacturer
   2. Drug Listing Number (Formerly NDC Number)
   3. Drug Registration Number (DUNS Number)

Medical Gowns

Medical Gowns that are going to a hospital or medical facility would be regulated by FDA as a medical device. There are several different types of gowns and can vary from within how they are regulated. When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether:

• They are labeled or otherwise intended for use by a health care professional;
• They are labeled or otherwise for use in a health care facility or environment;
• They include any drugs, biologics, or anti-microbial/anti-viral agents.

Medical gowns are divided into two classes, Class I and Class II. Class I devices would be a gown that is not intended for use as a “surgical gown” and has a minimal to low barrier protection, while a Class II device would be surgical gown that has moderate to high level barrier protection. These classes are determined by the FDA product code. The importer must know what FDA product code the product is registered with FDA under.

1. The following information must be reported to FDA for Class I medical devices:
   1. FDA Actual Manufacturer
   2. Device Foreign Exporter Registration Number (DFE)
   3. Device Listing Number for product (LST)
   4. Device Foreign Manufacturer Registration Number (DEV)

2. The following information must be reported to FDA for Class II medical devices:
   1. FDA Actual Manufacturer
   2. Device Foreign Exporter Registration Number (DFE)
   3. Device Premarket Notification number (510K)
   4. Device Listing Number for product (LST)
   5. Device Foreign Manufacturer Registration Number (DEV)