Foreign and domestic establishments such as (a) Manufactures (b) Initial Exporters (c) Initial Importers of Medical Devices intended to be sold in the USA must register and list with the FDA. It is mandatory to designate FDA US agents by establishments located outside the USA for better communication with the FDA Authorities.
The extent of Documented Information differs as per:
• Selecting the Medical Device and Models for USFDA approval
• Identify device code and Regulation Number along with verification of predicate device, indication and technology
• 510K compilation incorporating the pre-submission
• US Agent appointment
• Modify the 510K and provide additional supporting documentary evidences as per FDA review comments.
Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDA. food borne illness; and Quickly notify facilities that may be affected.