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Chances are you have received an email from someone who knows a company in China that can produce and ship N95 masks and other personal protective equipment that is currently facing a supply chain shortage in the US.

Owners or operators of places of business (also called establishments or facilities) 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).

On the FDA website, there is a searchable database of these establishments, before considering souring any product from any company, you should get their FDA Establishment License. The license doesn’t guarantee the product or the felicity are registered with the FDA, but it does show if the facility is registered to sell or distribute medical products in the US.

More information on FDA Establishment Licenses

Establishment Registration & Device Listing

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