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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.

Face Mask FDA Registration

Gown, Coverall, Face Shield, Face Mask Registration Process

Step I : Make sure you have DUNS Number .

DUNS Number is mandatory to make payments to FDA and to verify address.

We cannot initiate the process with out DUNS number.

Step 2 : US Agent Appointment

FDA US Agent is mandatory for Foreign manufactures and importers. Once appointed we will help create account with FDA for the annual fees transfer.

Step 3 : Establishment Registartion

FDA US Agent will apply for medical device establishment registration on behalf of your organization.

Step 4 : Label Compliance

It is the responsibility of the manufacturer to check and make sure the device label is in compliance with FAD regulation.

Step 5: Device Listing

Once your establishment is registered, Device listing must be completed. It shows what devices is sold in USA by the registered firm.

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?

DUNS number is mandatory to proceed with FDA Drug Establishment Registration and listing. DUNS Number is a unique nine digit identification number for physical location for your business, which you are planning to register with FDA.

Who will provide FDA Certificate?

FDA will not issue any FDA Certificate. We US Agents issue Certificate. Remember FDA will not recognize third party certificates.

Import regulation for face mask is different for sterile and non sterile ?

Yes, Non sterile items comes under class 1 and no FDA 510k clearance applicable.

What are the different types of N95 Masks FDA considered under medical device?

(a) N95 intended to prevent specific diseases or infections

(b) General Use.

 

Read more about N95 Face mask FDA Registration

N95 Mask has to clear FDA 510k before FDA Listing?

Yes. N95 intended to prevent specific diseases or infections is under FDA product code FXX need to clear 510k before FDA Registration and listing.

 

  1. more details about FDA 510k
  2. more details about FDA 510k Fees