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The United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a location in the United States to appoint a registered US FDA Agent. An appointed US FDA Agent must be a resident of the United States OR maintain a place of business in the US. Emergo Group serves as an official FDA Agent for more than 100 medical device and IVD companies from more than 25 countries worldwide.
Do contract manufacturers and sterilizers need to appoint a US Agent?
Yes, all foreign contract manufacturers and foreign contract sterilizers of finished medical devices or IVDs must appoint a US Agent regardless of whether the contract manufacturer/sterilizer puts the device into commercial distribution or returns the device to the customer.
Why appoint Emergo Group as your US FDA Agent?
- We act as a liaison between your company and the FDA, responding to questions concerning your products and assist you and the FDA to schedule inspections.
- We ensure that all regulatory responsibilities and interests of our clients are handled professionally, confidentially and promptly.
- We are a well established FDA US Agent representative in business since 1997.
- Emergo Group is an independent "third party" representative. We will always look after your interests. Manufacturers who appoint a distributor to act as their FDA US Agent can experience challenges in this regard. Read more about the benefits of appointing an independent US Agent.
- We can also represent your company as an in-country representative in 20+ other markets worldwide. No other consulting firm in the world offers a single source for representation in all of these markets.
* Please note that we do NOT provide FDA Agent representation for FOOD or PHARMACEUTICAL companies.
Please contact us for more information on US FDA Agent representation.