In Medical Devices

The documents listed below provide information on using color additives in medical devices, in compliance with regulatory requirements.

Resources

• Color Additives Listed for Use in Medical Devices (from the Code of Federal Regulations)
• Color Additives for Medical Devices
• PMA Special Considerations
• 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 Only)
• 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