Facility Registration and Listing
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Facility Registration and Listing
Our services include assistance with Establishment registration and device listing, Any establishment involved in the production, importation, reprocessing/relabeling, or developing specifications of a medical device or IVD for commercial sale in the United States must register annually with the US Food and Drug Administration (FDA). This is called "Establishment Registration" and it is a separate process from obtaining 510(k) clearance or PMA approval.
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