Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
This guidance outlines the requirements and procedures for color additive petitions in medical devices, specifically when the color additive comes in direct contact with the human body for a significant period of time, as per section 706 of the Federal Food, Drug, and Cosmetic Act.
Recommended Actions
- Contact Premarket Approval Staff to determine if color additive use is subject to section 706 requirements
- Verify if the color additive is already listed for the intended use
- If not listed, prepare color additive petition information according to 21 CFR 71
- Submit color additive information either as separate petition or as part of PMA
- Highlight the existence of color additive petition in PMA cover letter
- Ensure all required information is included directly in the submission rather than cross-referenced
- Account for potentially longer review period when color additive petition is involved
- Follow appropriate confidentiality provisions under 21 CFR 71
- Verify certification requirements for the color additive batch
- Consider seeking IDE exemption if the color additive is for investigational use only
Key Considerations
Safety
- Color additives must be listed for appropriate use according to section 706
- Color additives must be from a certified batch unless exempted
- Investigational device exemptions may be granted for color additives used solely for investigational purposes
Other considerations
- Color additive information can be submitted as part of a PMA application
- Information must be submitted in three copies when included in a PMA
- PMA approval is contingent on color additive listing
- Color additive petitions are processed by FDA Center for Food Safety and Applied Nutrition (CFSAN)
- Confidentiality provisions of 21 CFR 71 apply to color additive petitions in PMAs
Relevant Guidances
- Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
Related references and norms
- 21 CFR 71: Color Additive Petitions
- 21 CFR 73 (Subpart D): Listing of color additives exempt from certification for use in medical devices
- 21 CFR 74 (Subpart D): Listing of color additives subject to certification for use in medical devices
- 21 CFR 812: Investigational Device Exemptions
- 21 CFR 813: Investigational Device Exemptions for Intraocular Lenses
- 21 CFR 814: Premarket Approval of Medical Devices
Original guidance
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