[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: 21CFR73.3121]
 
 [Page 387-388]
 
                         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. 73.3121  Poly(hydroxyethyl methacrylate)-dye copolymers.
 
     (a) Identity. The color additives are formed by reacting one or more
 of the reactive dyes listed in this paragraph with poly(hydroxyethyl
 methacrylate), so that the sulfate group (or groups) or chlorine
 substituent of the dye is replaced by an ether linkage to
 poly(hydroxyethyl methacrylate). The dyes that may be used alone or in
 combination are
     (1) 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);
     (2) Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-
 N\29\,N\30\,N\31\,N\32\)-, sulfo((4-((2-
 sulfooxy)ethyl)sulfonyl)phenyl)amino) sulfonyl derivs] (CAS Reg. No.
 73049-92-0);
     (3) 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) Reactive Yellow 15 [benzensulfonic 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) Reactive Blue No. 19 [2-anthracene-sulfonic 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) Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-
 ((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-
 dioxo, disodium salt] (CAS Reg. No. 4499-01-8);
     (7) C.I. Reactive Red 11 [5-((4,6-dichloro-1,3,5-triazin-2-
 yl)amino)-4-hydroxy-3-((1-sulfo-2-naphthalenyl)azo)-2, 7-
 naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226-08-3);
     (8) C.I. Reactive Yellow 86 [1,3-benzenedisulfonic acid, 4-((5-
 aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-
 
 [[Page 388]]
 
 pyridinyl)azo)-6-(4,6-dichloro-1,3,5-triazin-2-yl)amino)-, disodium
 salt] (CAS Reg. No. 61951-86-8);
     (9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13-
 dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-triazin-2-yl)amino)
 sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847-56-4); and
     (10) 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).
     (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 dyes.
     (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 poly(hydroxyethyl
 methacrylate)-dye copolymer 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 additives shall conform to the
 requirements of Sec. 70.25 of this chapter.
     (d) Exemption from certification. Certification of these color
 additives is not necessary for the protection of the public health, and
 therefore these color additives are exempt from the certification
 requirements of section 721(c) of the act.
 
 [49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR
 9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18,
 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993]