FDA Establishment Registration for Testing Laboratories


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Is it required for testing laboratories (for Microbiological analysis like Bioburden, Sterility Test etc.) to be registered with FDA for Establishment Registration ?

The subject in question is for laboratories within US.

Thank you


No. There is no applicable registration category.

The exception to this would be if the lab also offered services that are considered to be production steps, such as contract sterilization; or if the lab also makes finished devices of some kind.

Nelson Labs, for instance, is registered, and offers the kinds of lab services you mention, but their registration is as a contract sterilization provider.
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