What is Medical Device Registration under US FDA?
Any facility which manufactures or handles any part of the process of manufacturing and shipping Medical Devices in USA needs to register with USFDA.
If a product is to be determined as a medical device it has to meet the definition of medical device as defined in Section 201(h) of the Food, Drug, and Cosmetic Act. Some example of medical device are – Tongue Depressor, Pacemakers, Measuring devices, thermometers, X ray machines , in vitro diagnostic products like blood glucose meter, covid testing kit, reagents etc are also considered as medical device. These are typically hardware device.
As of December 2019, the USFDA considers software used with the hardware as part of the Medical Device.
Who needs to register for Medical Device Facility under USFDA?
Owners or operators of establishments or facilities that are involved in the production and distribution of medical devices need to register with USFDA. These devices may be intended for use in the USA or maybe exported from USA.
Both Foreign and Domestic establishments are required to register with FDA
This registration is an annual process. It must be renewed every year. Process fees must be paid on a yearly basis.
The definition of establishment and the spectrum of services covered under the ‘production’ are:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Initial Importer
- Manufacturer
- Re-packager
- Re-labeler
- Remanufacturer
- Re-processor
- Specification Developer
All the above are required to register with FDA under medical device regulations
How to register for Medical Device facility with UDFDA
Primarily the FDA requires the manufacture to register its establishment and appoint a US Agent for Foreign facilities it also requires to list the device along with the activities that are performed on the device. It the device mandates a premarket submission then
- Most Class 1 Device can be listed directly without any PMN or PMA
- Pre- Market Notification – 510K- Mostly Required for Class II Device
- Pre- Market Approval – Mostly Required for Class III Device
- HDE – Humanitarian Device Exemptions – For Rare dieses or conditions
After this registration, a payment needs to be made for the annual registration. The payment can be made via:
- Electronic Payments (such as credit cards or ACH electronic checks).
- Mailing in a Paper check drawn on a U.S. bank in U.S. currency
- Wire Transfers
Renewal of Medical Device Facility and Fees for the same is to be done Every year before 31st Dec
- FDA Standard Fee for 510k is $12745.00 and subsidized fees for 510K submission for small business owners is $3186.00
- Annual Establishment Fees for FY 2022 is $5672.00