[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.3127]
 
 [Page 389-390]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                        Subpart D--Medical Devices
 
 Sec. 73.3127  Vinyl alcohol/methyl methacrylate-dye reaction products.
 
     (a) Identity. The color additives are formed by reacting the dyes,
 either alone or in combination, with a vinyl alcohol/methyl methacrylate
 copolymer, so that the sulfate groups of the dyes are replaced by ether
 linkages to the vinyl alcohol/methyl methacrylate copolymer. The dyes
 are:
 
 [[Page 390]]
 
     (1) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-
 ((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-
 naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0).
     (2) C.I. Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-
 5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-,
 tetrasodium salt] (CAS Reg. No. 17095-24-8).
     (3) C.I. Reactive Orange 78 [2-naphthalenesulfonic acid, 7-
 (acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-]
 (CAS Reg. No. 68189-39-9).
     (4) C.I. Reactive Yellow 15 [benzenesulfonic acid, 4-(4,5-dihydro-4-
 ((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-
 methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS Reg. No. 60958-41-0).
     (5) C.I. Reactive Blue No. 19 [2-anthracenesulfonic acid, 1-amino-
 9,10-dihydro-9,10-dioxo-4-((3-((2-
 (sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No.
 2580-78-1).
     (6) C.I. Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-
 N<SUP>29,</SUP> N<SUP>30,</SUP> N<SUP>31,</SUP> N<SUP>32</SUP>)-,
 sulfo((4-((2-(sulfooxy) ethyl)sulfonyl)phenyl)amino)sulfonyl
 derivatives] (CAS Reg. No. 73049-92-0).
     (b) Uses and restrictions. (1) The substances listed in paragraph
 (a) of this section may be used to color contact lenses in amounts not
 to exceed the minimum reasonably required to accomplish the intended
 coloring effect.
     (2) As part of the manufacturing process, the lenses containing the
 color additives are thoroughly washed to remove unbound reactive dye.
     (3) Authorization and compliance with this use shall not be
 construed as waiving any of the requirements of sections 510(k), 515,
 and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A
 person intending to introduce a device containing a vinyl alcohol/methyl
 methacrylate-dye reaction product listed under this section into
 commerce shall submit to the Food and Drug Administration either a
 premarket notification in accordance with subpart E of part 807 of this
 chapter, if the device is not subject to premarket approval, or submit
 and receive approval of an original or supplemental premarket approval
 application if the device is subject to premarket approval.
     (c) Labeling. The label of the color additive shall conform to the
 requirements of Sec. 70.25 of this chapter.
     (d) Exemption from certification. Certification of this color
 additive is not necessary for the protection of the public health, and
 therefore, this color additive is exempt from the certification
 requirements of section 721(c) of the act.
 
 [58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993]