Sunday, May 20, 2018 1:47:40 AM
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.
This database includes:
-- medical device manufacturers registered with FDA and
-- medical devices listed with FDA
Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
It's nice that they're listed as far as recognition goes, but I don't think it's an indicator one way or another about what will happen in the weeks to come (which will hopefully all be good). GLTA
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