FDA Provides Updates to the Instructions
for Filing Personal Protective Equipment
and Medical Devices During COVID-19

April 7, 2020

In CSMS #42272898, dated April 5, 2020, the U.S. Food and Drug Administration (FDA) published an update to CSMS #42168200 for instructions regarding the submission of entry information for personal protective equipment (PPE) and certain other devices.

Following the instructions outlined below will help facilitate the import process for all affected products, but particularly for products related to the COVID-19 public health emergency.

Non-FDA-Regulated General Purpose Personal Protective
Equipment (Masks, Respirators, Gloves, Etc.)

The FDA does not regulate PPE for general purpose or industrial use (i.e., products that are not intended to prevent disease or illness). For these types of products, entry information should not be transmitted to the FDA. Importers should transmit entry information to CBP using either:

  • An appropriate HTS code with no FD Flag, OR
  • An appropriate HTS code with an FD1 flag and doing a “disclaim” for FDA.

Importers need to be aware that marketing or labeling on the product can impact whether the article is FDA regulated on not. Only products marketed or labeled for general purpose or industrial use may disclaim FDA review.

Products Authorized for Emergency Use Pursuant
to an Emergency Use Authorization (EUA)

For products authorized for emergency use pursuant to an EUA, entry information should be submitted to the FDA. However, reduced FDA information is required for review. 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 are the products and appropriate product codes that are authorized by an EUA:

  • Diagnostic tests: 83QKP, 83QKO, 83QJR
  • Masks/Respirators: 80NZJ
  • Ventilators: See ventilator EUA for product codes

On April 3, 2020, in response to this evolving public health emergency and continued concerns about filtering facepiece respirator (FFR) availability, the FDA concluded, based on the totality of scientific evidence available, that certain product classifications for imported disposable FFRs, which are manufactured in China and not NIOSH-approved and for which data exists that supports the FFRs’ authenticity, are appropriate to protect the public health or safety (as described under section II Scope of Authorization) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized FFRs listed in Appendix A are authorized for use in healthcare settings by healthcare personnel (HCP)2 when used in accordance with CDC recommendations.

The FDA is issuing the April 3rd EUA to authorize disposable FFRs manufactured in China that meet certain criteria, including additional validation and review by FDA to confirm the FFR’s authenticity.

A full list of EUAs currently in place for the COVID-19 emergency is available on the FDA’s website. The import community is advised to check this site regularly for current information on products authorized by an EUA. For additional information issued by the FDA, go to the FDA page on COVID-19 EUAs or contact the FDA at 1-888-INFO-FDA, choose option *, or email: deviceshortages@fda.hhs.gov.

Products Regulated by the FDA as a Device, not Authorized by an EUA, but Where an Enforcement Discretion Policy has been Published in Guidance

For these products, entry information should be submitted to the FDA on entry. At the time of entry 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.

Below is a list of guidance documents that have been issued for specific products related to COVID-19. The guidance documents include applicable product codes and policy for the specific products.

  • 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

A full list of all guidance documents related to COVID-19 is also available on the FDA’s website. The import community is advised to check the FDA site for current information on these and other product areas.

For further information about these and other customs matters, contact George R. Tuttle, III at geo@tuttlelaw.com or 415-254-5986.

The information in this article is general in nature and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence and may not be considered as such.

Copyright © 2020 by Tuttle Law Offices. 
All rights reserved. 

Information has been obtained from sources believed to be reliable.  However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

 

 

 

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