QFI offers requisite Food and Drug Administration (FDA) point-of-contact and associated professional regulatory representation services to foreign establishments wishing to market goods such as medical devices and cosmetics, in the USA.

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 a United States Agent with the FDA.

QFI operational office in the USA and personnel act as US Agent for foreign establishments such as medical device manufacturers, attending to FDA enquiries related to product compliance, all types of inspections and documentation matters including notifications issued by FDA. QFI US Agent defends the manufacturer’s interests at all times. Specifically, QFI performs the following tasks on behalf of the manufacturer:

• Register foreign establishment and list product such as devices with the US FDA
• Assist in communications with the US FDA, including responding to questions posed by the US FDA concerning products imported into the USA and co-ordinating with the manufacturer
• Assist in scheduling inspections of the manufacturer’s site by the US FDA
• Handle appropriately any queries received from the US FDA, contacting the foreign establishment where necessary
• Handle any FDA immediate action request, eg, product safety notification
• Where required by a foreign establishment, report adverse events to FDA
• Where required by a foreign establishment, manage user studies conducted in the USA
• Identify and direct a foreign establishment attention to US safety and other standards
• Intervening in case of disagreement with FDA

QFI US technical specialists acting as QFI US Agent possess a wealth of industry and FDA experience, ranging from start-up to US multi-national corporates. We assist with DUNS verification and FURLS, determination of benefit-risk according to US guidance and examine adequacy of foreign establishment technical provisions, notably for products such as medical devices.

Working closely with other product/technology specialists in our team, the QFI US Agent is also involved in establishment inspections we conduct on a client’s operations to determine compliance status, for instance, to prepare our program clients for FDA inspections.