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FACE MASK, GOWN, GLOVES (Surgical) FDA 510k Process

Get more details how the certification process and cost involved in the 510k process.

Niosh Certification

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.

Face Mask FDA Registration Service

Gown, Coverall, Face Shield, Face Mask Registration Process

Step I : Make sure you have DUNS Number .

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

We cannot initiate the process without a DUNS numbers.

Step 2 : US Agent Appointment

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

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 : $ 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.

NIOSH Certification for N95 Respirator

The ultimate quality standard for N95 Face Mask. Get more details how the certification process and cost involved the NIOSH Certification of N95 Respirator.

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