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.
What You Need to Know? 👇
What medical devices require color additive petitions under FDA regulations?
Medical devices requiring color additive petitions include tinted soft contact lenses, dyed absorbable and nonabsorbable surgical sutures, and bone cements. Any device where color additives have direct contact with the human body for significant periods requires section 706 compliance.
Can color additive information be submitted as part of a PMA instead of a separate petition?
Yes, applicants may submit color additive petition information as part of their PMA application under 21 CFR 814.20(f) instead of filing a separate color additive petition under 21 CFR 71, provided the information is submitted in three bound copies.
How long does FDA review take for color additive petitions in medical devices?
Color additive petition review periods may be as long as, or extend beyond, PMA review timelines. The review is processed by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) according to procedures and fee schedules in 21 CFR 71.
What happens if a medical device PMA contains an unlisted color additive?
A PMA for a device containing a color additive subject to section 706 will not be approved until the color additive is properly listed for use in or on that specific device type under appropriate FDA regulations.
Where are approved color additives for medical devices listed in FDA regulations?
Approved color additives for medical devices are codified under 21 CFR 73 (Subpart D) if exempt from certification requirements, or under 21 CFR 74 (Subpart D) if subject to batch certification requirements.
What confidentiality rules apply to color additive petitions submitted with PMAs?
Color additive petitions included in PMA submissions are subject to confidentiality provisions under 21 CFR 71 rather than the standard PMA confidentiality provisions under 21 CFR 814, which may affect information disclosure and protection.
What You Need to Do 👇
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 🔗
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