Get more details how the certification process and cost involved in the 510k process.
Face Mask FDA Registration Service
Best US FDA Consultants & US Agents for Medical Gown, Coverall, Face Shield, N95 Face Mask US FDA Registration Service for those looking to export to the USA. This service is only for manufactures. More information about FDA registration and listing detailed below.
Gown, Coverall, Face Shield, Face Mask Registration Process
Step I : Make sure you have DUNS Number .
We cannot initiate the process without a DUNS numbers.
Step 2 : US Agent Appointment
Step 3 : Establishment Registartion
Step 4 : Label Compliance
Step 5: Device Listing
Gown, Coverall, Face Shield, Face Mask Registration Fees and Timeline
Mandatory Service Fees
- US Agent Service and Establishment registration : $ 449/ FY
- Device Listing : $ 50 / Device
- US FDA Fees for the FY 2019- 2020 : $ 5236 ( Customer should pay direct to US FDA)
Optional Service Fees
- Label review : $ 649/Device [ 14-20 working days]
- FDA Code validation, Technical Guidance, Application submissions, DUNS support : $ 600-1000 depending on the number of devices.
Is DUNS mandatory for FDA Medical Device Establishment Registration?
Who will provide FDA Certificate?
Import regulation for face mask is different for sterile and non sterile ?
What are the different types of N95 Masks FDA considered under medical device?
(b) General Use.