Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register with the U.S. Food and Drug Administration.
Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Failure to register is a prohibited act. Finally, a medical device is misbranded if it is manufactured in an establishment not duly registered.
When you seek the assistance of an FDA Consultant or U.S. Agent including ITB HOLDINGS LLC, a Service Fee will be due.
- 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
Annual Establishment Registration: $7,653.
Premarket Notification 510(k) application: $5,440 (with Small Business Certification).
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.
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.
Under the provisions of 42 CFR 84, the National Institute for Occupational Safety and Health (NIOSH) is authorized to:
▪ establish procedures and prescribe requirements which must be met in filing applications for approval by NIOSH of respirators or changes or modifications of approved respirators.
▪ set schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part.
▪ provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part.
▪ specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.