USA | FDA Agent

Your FDA Agent in the United States

We ensure that your medical devices comply with FDA regulations, ensuring swift and secure access to the US market.

At CMC Medical Devices LLC, we assist all manufacturers of medical devices and IVDs without a US headquarters by serving as their exclusive FDA agent. We provide expert guidance throughout the regulatory process and act as an intermediary connecting your company with the FDA.

CMC offers comprehensive assistance with the FDA registration process, ensuring that your products meet all regulatory standards.

510(K)

If you need to submit a 510(k) application in the US, CMC can assist you. We specialize in guiding medical device manufacturers through the submission process to the FDA.

UK FSC

CMC can also apply for the FDA Free Sale Certificate (FSC) for any country worldwide, including country-specific legalisation.