Register establishment and list devices with FDA establishing legal presence for US market access.
When do I need to complete FDA registration and listing?
What is the difference between FDA registration and 510(k) clearance?
Do I need a US Agent if I'm a foreign company?
How often do I need to renew my FDA registration?
What happens if I make changes to my software after FDA clearance?
How do I determine the correct product code for my software device?