The FDA medical device registration process involves multiple steps to ensure the device meets safety and regulatory standards.
Registration Requirements: The FDA classifies devices into various risk categories Class I, II, III based on their complexity and potential risks. Based on their classification, the registration requirements vary. For critical devices, first they must get 510K clearance or PMA and then register.
Pay the Registration Fee: The FDA requires an annual registration fee for device establishments. Companies can make the payment by creating a user fee account with FDA and obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN).
Obtain a FURLS Account: The FDA uses the Facility and Registration Listing System (FURLS) for device establishment registration and product listing. Companies must create a FURLS account to complete the registration process.
Register the Facility: Register the establishment that manufactures or distributes the medical device with the FDA through FURLS. This involves providing details like owner information, facility location, and the type of activities your establishment performs related to the device.
Device listing: Once the facility is registered, list the specific medical device in FURLS. Devices can be identified with the product codes which indicate if the device needs premarket notification or 510k number. If product code needs 510K clearance or PMA, then the device must be listed with appropriate 510K or PMA numbers.
All medical device establishments must renew their registration between October 1st and December 31st every year if they want to market the device in the next FY.
Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us