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US FDA Registration and Approval for Face Mask

We provide complete solutions for Face Mask FDA Registration & Approval. Contact us now!!!

General purpose face mask does not come under FDA preview and such items can be marketed without FDA Registration and listing.

General purpose face mask with health claims or non Sterile / Sterile gloves falls under FDA 510k non-exempted category. Such devices FDA registration and listing mandatory after 510k approval.

Refer below the cost.

  • US Agent Annual Fee : 449 USD
  • FDA annual fee for the year 2020 : 5236 USD
  • Device Listing : 50 USD / Device
  • US FDA 510k : Click Here>>
  • DUNS support (Optional) : Contact us

N95 face mask and similar face masks with medical / health claims must clear 510k before FDA registration & Listing.

If you are looking for GMP /Medical Device 21  CFR 820  related fees, Click Here

Please contact us for more details.