In response to COVID-19, the U.S Food and Drug Administration released new guidelines on March 24, 2020 for manufacturers importing personal protective equipment and other apparatuses. FDA’s priority is to facilitate access to personal protective equipment to gain an upper hand on COVID-19. The U.S Food and Drug Administration stated
“We are engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries. We have adjusted our import screening to further expedite imports of legitimate products and are continually monitoring our import systems to prevent and mitigate any potential issues.”
Learn more by visiting their website.
The FDA is allowing the use of personal protective equipment (PPE) for general or commercial use even if it’s not regulated by the FDA. For PPE items, import information will not be required to be transmitted to the FDA. At the time of entry, Importers must transmit the entry information to US Customs and Border Protection services using an appropriate Harmonized Tariff Schedule (HTS) code. The HTS codes are flagged with indicators to help guide whether FDA data is required.
If you have questions about the FD flag on an FDA regulated commodity, please contact the Division of Import Operations: by phone 301-796-0356 or email FDAImportsInquiry@fda.hhs.gov
FD Flags
The HTS code for your product will most likely be associated with an FD flag. This flag acts as an indicator to the customs broker/entry filer that your product needs to be transmitted to FDA for review.
| Flag | Meaning | Examples |
|---|---|---|
| FD1 | May or may not be regulated by FDA: If regulated by FDA, submit entry information; if not regulated by FDA, disclaim | Certain chemicals used in manufacturing drug products vs. industrial use; safety goggles for medical use vs. non-medical use |
| FD2 | Regulated by FDA, but is not food: Submit entry information | Medical Devices, Drugs, Tobacco, and Cosmetics |
| FD3 | May or may not be a food product: If yes, submit Prior Notice (PN) and entry information; if no, disclaim | Salt used for flavoring food vs salt used for treating road surfaces |
| FD4 | Food product: Submit PN and entry information | Fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients |
When importing items for “medical” or “hospital” use, entry information is still required to be submitted for FDA review. Products covered by an emergency use authorization (EUA)—such as diagnostics, masks, and respirators—should be transmitted by importers by an Intended Use Code of 940.000: Compassionate Use/Emergency Use and the appropriate product code for the device.
As manufacturers are working hard to provide these products, importers are going through great lengths to get these essentials in the hands of hospitals and the public. The FDA is working with importers and provide maximum flexibility for PPE products seeking entry into the United States.
Contact
If you any import or exporting questions, give us a call at: (305) 821-8995
