Medical devices imported into United States need to comply with FDA regulations.
Prototypes for testing purposes do not need FDA registration. When entering the United States, they need to be cleared by FDA before distribution for testing. FDA may need a letter explicitly stating these products are testing prototypes not sold to the general public.
Devices sold to the general public require FDA registration by both the manufacturer and the importer. Registrations fees are also required. The following better illustrates the type of establishments who must register for their medical devices and also the most recent changes to the registration and listing requirements: Click here.
510K Pre-market notification may also be a requirement and is at the discretion of FDA. Click here for more information.
To view existing FDA product listings: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm