Personal Protective Equipment (PPE) refers to gowns, gloves, face shields, goggles, facemasks, and respirators or other equipment designed to protect the wearer from the spread of infection or illness.
PPEs are regulated by the FDA as medical devices.
We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not representing your products as safe and or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA, and that you do not make claims that adulterate or misbrand the products.
EUAs were issued by the FDA using the following criteria:
1. SARS-CoV-2, the virus that causes COVID-19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus
2. Based on the totality of scientific evidence and other information available to FDA, it is reasonable to believe that the products may be effective in preventing wearer exposure to pathogenic biological airborne particulates during filtering facepiece respirator (FFR) shortages, and that the known and potential benefits of the authorized respirators, when used for such use, outweigh the known and potential risks of such products
3. There is no adequate, approved, and available alternative to the emergency use of these respirator models for preventing healthcare personnel or providers (HCP) exposure to such particulates during FFR shortages to prevent disease spread during the COVID-19 emergency.
EUAs are effective until the declaration that circumstances exist justifying the authorization of the emergency use of personal respiratory protective devices during the COVID-19 outbreak is terminated or the EUA is revoked.
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.
Is your company manufacturing, exporting or distributing other medical devices?
FDA is using DUNS Numbers issued by Dun & Bradstreet Inc, to conduct verification of medical device facility information provided to the agency by registered and listed medical device manufacturers. A DUNS Number is required. There is no exemption for domestic and foreign companies.
Moreover, foreign companies must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the facility and FDA. The U.S. Agent is authorized to register any establishment.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
Service Fees are due each time you seek and request the assistance of an FDA Consultant or U.S. Agent, including ITB HOLDINGS LLC.
FACILITY
REGISTRATION
$350.00
- Company Registration
- Product Listing
- U.S. Agent Service
Under the Medical Device User Fee Amendments (MDUFA), medical device companies pay fees to the FDA when they register their establishments and list their devices.
Fiscal Year 2024 User Fees.
Annual Establishment Registration: $7,653.
Premarket Notification 510(k)
– Small Business Fee: $5,440.
– Standard Fee: $21,760.
Exempt medical devices do not incur this fee.
Additional fees may apply.
Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package, is an Initial Importer.
Contact ITB HOLDINGS LLC, for additional information.