According to FDA regulations 21 CFR Section 807.20 and 807.40, the following types of companies must register with FDA:
Contract manufacturers, including contract packagers
Manufacturers located in a Foreign Trade Zone
If the company maintains complaint files under 21 CFR 820.198
Manufacturer of accessories or components
Manufacturer, including kit assemblers
Manufacturer of custom medical devices
Relabeler or Repacker
Reprocessor of single-use devices
US Manufacturer of export only devices
Medical device manufacturers and others are required to register their facilities with FDA and renew those registrations on an annual basis. The registration renewal process occurs between October 1 and December 31 of each year.
There is a fee associated with medical device registration. The fee varies but is usually around $4,000 - $5,000.
All medical device registrations must be submitted electronically through FDA's website unless a waiver is granted. The registration is a two-step process, first, the fee must be paid to FDA then the registration can occur. The time frame between the payment and final registration is typically one week. Once a medical device registration has been completed the contact email address will receive a confirmation email.
Initial importers that are seeking to register as a medical device establishment must identify their manufacturers within FDA's online system otherwise the electronic application can not be submitted.