Face Mask FDA Registration Service
Best US FDA Consultants & US Agents to for Medical Gown, Coverall, Face Shield, N95 Face Mask US FDA Registration Service for those looking to export to 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 with out DUNS number.
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 : $649/ FY [ 2 working days]
- Device Listing : $150 / Device [2 working days]
- 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]
- DUNS Support : $100 [7-14 working days]
- Guidance / Consultation : Fees starts from 500 USD depending on 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.