About Medical Device Establishment Registrations
Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA on an annual basis. Medical device facility registration information must be verified annually between October 1st and December 31st of each year.
In addition to registering their medical device facility, foreign manufacturers must also designate a U.S. Agent. The U.S. Agent is a person or entity that maintains an address in the United States who can serve as the facilities representative before the FDA. Every importer of medical device products to the United States must provide to the FDA with the medical device facility registration number for the foreign drug manufacturer and importer/distributor. Failure to provide this information will result in a detention or refusal of the medical device products.
Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. The schedule of medical device registration fees for fiscal years 2016 to 2017 are as follows:
Domestic establishment registration: $3,982 ($3,382 government registration fee + $600 service fee)
Foreign establishment registration: $4,332 ($3,382 government registration fee + $950 service fee)
Domestic establishment registration: $4,445 ($3,845*- government registration fee + $600 service fee)
Foreign establishment registration: $4,795 ($3,845*- government registration fee + $950 service fee)
Most medical device establishments that are required to register with the FDA are also required to list the medical devices that are manufactured at the facility and the activities that are performed on those devices. For more information on how to list a medical device product and obtain a medical device listing number, click here.
FDA Solutions Group’s medical device specialists help businesses comply with U.S. FDA medical device registration and listing requirements. To begin registering your medical device facility now, please click the appropriate option below: