FCC Representative

THE FEDERAL COMMUNICATIONS COMMISSION (FCC) AND WIRELESS MEDICAL DEVICES

Medical devices that incorporate wireless technology introduce some unique risks that should be addressed. The Radio Frequency Wireless Technology in Medical Devices provides recommendations to develop and support safe and effective wireless medical devices. The FDA's policies on wireless medical devices are coordinated with the FCC and provide medical device manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize these technologies

The Federal Communications Commission (FCC) requires foreign manufacturers to appoint a US Agent for Service of Record to act as their representative in the United States:

2.911 Application requirements FCC Part 2.911(d)(7) is a section of the Federal Communications Commission (FCC) rules and regulations that pertains to the designation of a US Agent for Service of Record. The purpose of this section is to ensure that telecommunications companies operating in the United States appoint a designated representative who can receive and handle legal notifications and documents on behalf of the company.

Legal Representation of your products in the USA

AVOID PENALTIES AND FINES

These fines are not just one-time fees but can accumulate over time, severely impacting your business's bottom line.

PREVENT PRODUCT RECALLS

In the event of Safety concerns, mandatory recalls may be required.

ENSURE MARKET ACCESS

Non-compliant products may be barred from being sold, limiting your company's growth and revenue opportunities.