U.S. FDA Registration & Labeling Compliance Assistance

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.