- FDA Product Registration: Register your product today
- The U.S. Food and Drug Administration regulates all food and medical products that are sold in the United States of America. Each product has a different process for approval and registration depending on product use and product type.
Owners or operators of places of that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807). U.S. Congress has authorized FDA to collect an annual establishment registration fee for device establishments. A detailed list of the types of device establishments that are required to register and pay the fee can be found at “Who Must Register, List and Pay the Fee”. The establishment registration fee is not eligible for a reduced small business fee. All registration and listing information must be submitted electronically, unless a waiver has been granted. Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Visit the FDA website for more information to get your product registered for sale in the United States.
- Files Needed for Registration
- The following information is needed in order to register your product with the FDA. They include Contact Addresses, Listing Establishment Types, Listing PCD, Listing Proprietary Name, Official Correspondent, Owner Operator, Registration, Registration Listing, US Agent, Establishment Types, Non-Registered Importers Identified by Manufacturers, Manufacturers Identified by Importers, Registered Importers Identified by Manufacturers. Visit the FDA website for more information to get your product registered for sale in the United States.
- FDA Product Registration Search: Search to see if a product is registered with the FDA
- When purchasing a product, you always want to make sure that it meets your needs and the specifications that the product claims it meets. To do so, simply visit the FDA Product Registration Search Page and input Registration or FEI Number and click on the “Search” button to find the product you are researching.
- Search for NIOSH (National Institute for Occupational Health & Safety) Approved Products with the CDC
- The Occupational Safety and Health Act of 1970external icon established NIOSH as a research agency focused on the study of worker safety and health, and empowering employers and workers to create safe and healthy workplaces. NIOSH is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. It has the mandate to assure “every man and woman in the Nation safe and healthful working conditions and to preserve our human resources.”
For NIOSH Approved respirators/masks, simply enter the NIOSH TC approval number(s) separated with semi-colon; Each class of respirator must be entered separately. All products are tested and certified by the National Personal Protective Technology Laboratory (NPPTL).
- Search for FDA Press Releases and Updates
- Rules and Regulations can change at any time. Stay up to date with all news and announcements made by the FDA here. Press announcements from 2013 to 2016 and 2017 are available through the gov . Some links in press announcements may no longer be active. For more information, contact FDA’s Office of Media Affairs at 301-796-4540.
- Directory for Certified Inspectors Worldwide
- ShopUST performs due diligence and vetting of all suppliers and manufacturers who have their products listed on ShopUST.com. However, it is strongly encouraged that each buyer inspects their purchase on their own. In most cases, you may not be able to physically inspect your purchase yourself. Whether you are arranging for your own shipping or the supplier/manufacturer is handling the shipping for your purchase, it is important that you have an independent third party inspect the product to be shipped. They will sign off on the product after doing random inspections of the actual products that is schedule to be shipped. They usually do it at the factory, unless the manufacturer has a bonded warehouse at port where it can be checked there as well. Either way, it is suggested that you do not make final payment to the supplier until the product is inspected.
- PPE Product Registration and News for Market Access in the European Union Member Nations
- When purchasing a product, you always want to make sure that it meets your needs and the specifications that the product claims it meets. To do so, simply visit the European Commission Product Registration Search Page to ensure the product you wish to purchase confirms to the guidelines required by the European Commission. The EC has also published guidance for manufacturers to help economic operators to assess whether they can convert their existing facilities to produce protective equipment. It details applicable EU legal frameworks and steps that manufacturers need to take to place their products on the EU market.
- EUA List- Emergency Use Authorization- Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
To see the list of approved non-NIOSH masks/respirators, please follow this link and scroll down towards the bottom to see which products are authorized by the FDA’s Umbrella EUA for emergency use during the COVID-19 public health emergency.