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.

We submit your 510(k) application in the USA

UK FSC

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

We register your products in the USA

Select CMC as Your FDA Agent in the United States

Complete the contact form and one of our consultants will get in touch as soon as possible.

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Why appoint CMC Medical Devices?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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