For Industry
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In Medical Devices
The documents listed below provide information on using color additives in medical devices, in compliance with regulatory requirements.
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Resources
- 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 Only) (PDF - 91KB)Guidance for Industry and FDA Staff - Medical Glove Guidance Manual 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
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