The documents listed below provide information on using color additives in medical devices, in compliance with regulatory requirements.
- Color Additives Listed for Use in Medical Devices (from the Code of Federal Regulations)
- Color Additives for Medical Devices
PMA Special Considerations Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses Color Additive Petitions(PDF - 91KB) FDA Public Health Advisory: Subject: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C Blue No. 1