March 31, 2020
Information for filing entries of personal protective equipment and medical devices during COVID-19
The Food and Drug Administration (FDA) recently provided instructions regarding the import of personal protective equipment and other medical devices during the COVID-19 public health emergency. Cargo Systems Messaging Service (CSMS) message #42124872 from United States Customs and Border Protection (CBP) lays out this information, grouping personal protective equipment (PPE) and medical devices into multiple categories. Further information was provided in CSMS #42168200.
1. General-purpose PPE such as masks, respirators, gloves, etc. not Food and Drug Administration (FDA) regulated
These products are PPE intended for non-medical use (example, general-purpose or industrial use) and are not intended for use to prevent disease or illness – as an example paint or dust masks or respirators that could be purchased at a hardware store. They are not a medical device nor intended to be used as one, nor are they classified as medical devices by the FDA. These products do not require entry information to be transmitted to the FDA. A correct Harmonized Tariff Schedule of the United States (HTSUS) tariff code should be utilized that either has no FD flag or an FD1 flag – in the case of the latter, a disclaim should be submitted for FDA.
2. FDA-regulated medical devices and PPE authorized for emergency use pursuant to an Emergency Use Authorization (EUA)
These products are medical devices and PPE that require FDA entry submission. The specified products should have Intended Use Code 940.000: Compassionate Use / Emergency Use and an appropriate FDA product code applied to speed up FDA review and release. Reduced FDA information is required for review if a device falls under EUA – the reporting of Affirmation of Compliance codes such as the registration, premarket numbers and the listing number is not required.
Three FDA product codes for diagnostic tests (83QPK, 83QKO, 83QJR) and one FDA product code for a mask/respirator (80NZJ) are covered under EUA per CSMS # 42168200. Other types of masks would fall under the “all other FDA-regulated products section” listed below. Product code 80NZJ covers N95 style respirator masks for use by the general public. Specifics on N95 style masks can be found on the FDA’s website. More information on EUA can be found on the FDA EUA page.
3. Products regulated by FDA as a device not authorized by an EUA, but where an enforcement discretion policy has been published in guidance
These products are medical devices and PPE that require FDA entry submission. The specified products should have Intended Use Code 081.006: Enforcement discretion per final guidance and an appropriate FDA product code applied to speed up FDA review and release. Reduced FDA information is required for review if a device falls under enforcement discretion policy – the reporting of Affirmation of Compliance codes such as the registration, premarket numbers and listing number are optional.
Other FDA-regulated medical devices and PPE that fall outside the scope of the Emergency Use Authorization or Enforcement Discretion Policy still require all standard FDA data elements to be reported (e.g., LST #, DEV #, DFE #) and an appropriate FDA Intended Use Code – FDA Intended Use Codes 940.000 (Compassionate Use) or 081.006 (Enforcement discretion per final guidance) would not be acceptable for these items.
Guidance documents from FDA on products related to COVID-19 can be found at the links below:
- Face Masks and Respirators
- Ventilators and Accessories and Other Respiratory Devices
- Non-Invasive Remote Monitoring Devices
- Diagnostic Tests
A complete list of FDA guidance documents related to COVID-19 is also available.
For more information, please contact your local FedEx Trade Networks Transport & Brokerage office. For a complete list of office locations, go to http://www.ftn.fedex.com/us/locations.
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