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  1. Biocompatibility Assessment Resource Center

Color Additives For Medical Devices

Introduction

Under certain conditions, color additives in medical devices are subject to the same provisions that apply to color additives in foods, drugs and cosmetics. The Food, Drug and Cosmetic Act (the Act) states that devices containing a color additive are considered adulterated unless a regulation is in effect listing the color additive for which it is intended to be used (see Sec. 721(a) of the Act). The color listing regulation may permit use of the color additive in a generic type of device, such as contact lenses, or may place limitations on its use, such as polypropylene nonabsorbable sutures for general surgical use but not for ophthalmic surgical use. The Act limits applicability of these provisions to color additives that directly contact the body for a significant period of time. At the present time, the term a "significant period of time" is not defined by FDA regulation.

Color Additive Defined

1) The term "color additive", as defined under section 201(t) of the FD&C Act, means a material which:

A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and

B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary [of the Department of Health and Human Services] by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

2) The term "color" includes black, white and intermediate grays.

FDA-regulated products must comply with the color additive regulations. Color additive violations are common reasons for warning letters and import detentions.

Below are links to FDA’s color additive regulations and related resources.

Links to the Electronic Code of Federal Regulations (eCFR)

21 CFR Part 70 - Color Additives
These regulations address general provisions for color additives, their packaging and labeling requirements, and the fees for filing a color additive petition to list a new color additive or a new use for a listed color additive.

21 CFR Part 71 - Color Additive Petitions
These regulations describe how to submit a color additive petition to FDA as well as the information FDA requires in order to evaluate the petition.

CFR Part 73 - Listing of Color Additives Exempt from Certification
These regulations list the FDA-approved color additives that are exempt from FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 74 - Listing of Color Additives Subject to Certification
These regulations list the FDA-approved color additives that are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 80 - Color Additive Certification
These regulations state the fees for color additive certification and describe the certification procedures and requirements.

21 CFR Part 81 - General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
These regulations include the provisional lists of color additives and the color additives whose provisional listings have been terminated.

21 CFR Part 82 - Listing of Certified Provisionally Listed Colors and Specifications
These regulations list the provisionally listed color additive lakes, which are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives. (All color additives were provisionally listed in response to the 1960 color additive amendments to the Federal Food, Drug, and Cosmetic Act. Only lakes, which are insoluble pigments formed from color additives listed in 21 CFR part 74, remain provisionally listed.)

Additional Resources

Color Additives - FDA's Regulatory Process and Historical Perspectives: An article on FDA’s regulation of color additives

Color Additive Petitions: Resources for submitting a color additive petition

Color Certification: Resources on FDA’s color certification process

Color Additive Inventories: Quick-reference tables with important regulatory information

Federal Food, Drug, and Cosmetic Act: See sections 201(t) (U.S.C. 321(t)) for definitions and 721m (21 U.S.C. 379e) for general authority

CDRH Learn FDA Webinar: Color Additives For Medical Devices (February 2016): Includes an overview of the FDA’s current policy on color additives for medical devices and the agency’s approach to the evaluation of marketing applications (i.e. premarket notifications (510(k)), premarket approvals (PMA), de novo requests, and Humanitarian Device Exemptions (HDE) for medical devices containing color additives. It is intended to help medical device manufacturers understand current FDA policy on the use of color additives for medical devices and is part of the agency’s ongoing industry education on the regulation of medical devices.  This module is located in the Specialty Technical Topics folder under the subtopic Biocompatibility.
 

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