Companies who are involved in manufacturing, testing, packing, labeling, sterilization, or import of medical devices are required to register their facility, pay FDA registration fees, and list their devices with the FDA. Medical device companies must also review their medical device establishment registration and listing information annually and renew their registration.

U.S FDA Services offers FDA medical device registration and listing services at competitive fees. With over 10 years of experience, we can provide expert advice on all regulatory requirements for medical devices. Our complete solution will give you the support you need until you have met all the FDA medical device regulations.

Please note, medical device facilities are also required to pay FDA registration fees (for 2022, $6493). We can help you set up your account and create your PIN to pay your fees directly to the FDA accounts