There is a tremendous amount of confusion in regards to what the FDA terms “approved” and “registered” are referring. Let’s take a deeper dive on this….
FDA REGISTRATION / OWNER OPERATOR NUMBER
Owners or operators of places of business (also called establishments or facilities) that are involved in the production/distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration. In China, you will see third-party registrations such as this to the right:.
“FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and listing does not denote approval or clearance of a firm or their devices.” –FDA.gov
Most establishments that are required to register with the FDA are also required to list the devices that are made there, and the activities that are performed on those devices. A Company is given an Owner/Operator Number that can be validated on https://www.accessdata.fda.gov/.
This simply means the MANUFACTURER has only registered their company, but this DOES NOT mean that their products have been tested and/or approved for medical use. The filtering capacity cannot be guaranteed.
An Emergency Use Authorization for Medical Devices was issued to help
deal with the shortage of respirator masks ,and included Non-NIOSH
KN95 respirator masks to be used in the United States. The FDA then
created an official list of manufacturers that had met all applicable FDA
safety standards called the “Non-NIOSH-Approved Disposable Filtering
Facepiece Respirators Manufactured in China.”
This is the ONLY FULLY AUTHORIZED AND APPROVED list of manufacturers
whose products have been tested and have been verified, to be imported into the US for use in hospitals, clinics and other health care facilities.
ALL Urgent Medical Supply manufacturers can be found on the FDA APPROVED respirator mask list ensuring the highest levels of compliance, safety and quality.
To clarify this further, we have taken our KN95 masks (FDA Approved) and did a side-by-side comparison with another FDA registered mask that is currently in circulation. Pictures speak louder than words…