Circuitwise is pleased to announce it has been registered in the United States Federal Drug Administration’s FURLS database as a contract manufacturing establishment for medical devices. This establishment registration will assist any clients exporting their products to the United States.
Any company involved in the manufacturing of medical devices sold in the United State must be registered as an official establishment associated with that product. This applies to the registered manufacturer, any contract manufacturer, specification developer and sterilization provider, among other categories.
FURLS is an acronym for FDA Unified Registration and Listing System. It is the system the FDA provides for applicants to register online and make electronic submissions. Establishments must reregister annually, and this system facilitates easy updates to the information provided. Information updates include listing the range of medical devices a contract manufacturer is involved in, that are marketed in the US, and the activities performed.
Establishment registration is a separate process from obtaining regulatory approval for a device, typically through a 510(k) clearance or Premarket Approval (PMA).