Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote clearance or approval of the establishment or its products by the FDA.
The FDA does not expect manufacturers of face masks for a medical purpose, that are not intended to provide liquid barrier protection, to submit notification to the FDA before they begin marketing their product, or to comply with certain regulatory requirements, where the face mask does not create an undue risk.
If a face mask, surgical mask or respirator requires a premarket submission prior to marketing (not exempt), the manufacturer must wait until it receives FDA clearance or approval before registering and listing.
It is in the best interest of the U.S. to facilitate and expedite the importation of products into the U.S. market that address immediate, urgent public health needs. To help expedite FDA review of entries, it is recommended that product label/labeling and an intended use letter are uploaded into the Import Trade Auxiliary Communication System (ITACS) at the time of entry.
When importing products authorized pursuant to an Emergency Use Authorization (EUA), reduced FDA information is required for review. At the time of entry, importers 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 the U.S. Customs and Border Protection’s Automated Commercial Environment (ACE) system.
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices are no longer authorized for use in healthcare settings, as access to FDA-authorized and NIOSH-approved N95s increases nationwide.
- Company Registration
- Product Listing
- U.S. Agent Service
All establishments that are required to register must pay an annual registration user fee.
$5,672.00 | Establishment Registration, (FY 2022 – October 1, 2021 through September 30, 2022).
The establishment registration fee is not eligible for a reduced small business fee.
$3,186.00 | Premarket Notification 510(k), single payment
Small Business Fee | (FY 2022 – October 1, 2021 through September 30, 2022).