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FDA Color Additive Requirements

FDA Color Additive Requirements

U.S. FDA strictly regulates the color additives that are being used in any part of the manufacturing process of medical devices . All color additives must be properly declared on the product labels. Use of unapproved color additives violates FDA regulations.

For the color additives used in medical devices, U.S. FDA requires that manufacturers receive either batch certification or otherwise get an exemption by FDA. To obtain the color additive batch certification, manufacturers must submit a sample of the Color Additive for each batch as well as the required paperwork. After proper examination, U.S. FDA will certify your color additive if the analysis of the sample meets the FDA requirements.

FDA Listing Inc. assists medical device manufacturers in demonstrating to FDA that the color additives used in their manufacturing are certified, and approved by FDA. We initially provide you with an assessment of your color additive to determine if batch certification is needed or not. If so, our experts we will assist you through filling for batch certifications and the approval process. For assistance regarding color additive review and batch certification click the start button in the front.


To request a quote about "FDA Color Additive Requirements" submit US FDA Registration Help form or call us at +1 929-376-7870 to speak with one of our agents for help.

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Contact Info:
Address:82 Nassau St,New York,NY 10038,USA
Phone: +1 929-376-7870

 Service & Fees:


  • Color Additive Initial Assessment , Free
  • FDA Batch Certification Submission Assistance, 295 USD
  • FDA Account Registration, Free Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.

U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info