Description
This guidance provides FDA's recommendations on color additives information to include in a premarket application.
Scope & Applicability
Product Classes
3Bone cements
Subject to color additive requirements
Surgical sutures
Dyed absorbable and nonabsorbable sutures subject to section 706
Soft contact lenses
Subject to color additive requirements
Stakeholders
1Premarket Approval Staff
Staff to contact for assistance in determining contact period
Regulatory Context
Attributes
1Direct contact
Contact with the human body for a significant period of time
Related Warning Letters (5)
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (8)
- CPG Sec 500.425 Use of Color Additives in Paper and Paperboard Intended for Use with Food (Status: Final)
- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (Status: Draft)
- CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal Foods (Status: Final)
- Using the Inactive Ingredient Database Guidance for Industry (Status: Draft)