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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.

  1. Contact Premarket Approval Staff to determine if color additive use is subject to section 706 requirements
  2. Verify if the color additive is already listed for the intended use
  3. If not listed, prepare color additive petition information according to 21 CFR 71
  4. Submit color additive information either as separate petition or as part of PMA
  5. Highlight the existence of color additive petition in PMA cover letter
  6. Ensure all required information is included directly in the submission rather than cross-referenced
  7. Account for potentially longer review period when color additive petition is involved
  8. Follow appropriate confidentiality provisions under 21 CFR 71
  9. Verify certification requirements for the color additive batch
  10. 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

  • 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

  • Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
  • HTML / PDF
  • Issue date: 1987-06-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: a64a51cf5f926059db6fb890dcc89f81
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