The US Food and Drug Administration (FDA) requires that any establishment engaged in the manufacture, preparation, propagation, compounding or processing of a drug or device imported into the United States of America (USA) be registered with them. Any manufacturer without a place of business in the USA is designated as a foreign establishment and must appoint and register with the FDA, a United States Agent. 

QFI has a fully operational office in the USA, allowing them to act as US Agent for device manufacturers, and from where they defend the manufacturer’s interests at all times. Specifically, QFI perform the following tasks on behalf of the manufacturer:

  • Register the foreign establishment and list the devices with the US FDA
  • Assist in communications with the US FDA, including responding to questions posed by the US FDA concerning the products imported into the USA
  • Assist in scheduling inspections of the manufacturers site by the US FDA
  • Handle appropriately any queries received from the US FDA, contacting the foreign establishment where necessary

US FDA Clearance

Quality First International provides: Designation and classification of your device Register your establishment Preparation of Premarket Notification 510(k) submissions Complete Product Development Protocols Secure Investigational Device Exemption (IDE) When entering the US marketplace, a medical

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Scientific and clinical literature services

QFI is a leading provider of scientific and clinical literature research on medical devices. We produce high-calibre grounded-theory, thematic and phenomenological publication quality clinical evaluations designed to fulfil medical devices clinical data by literature search

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