[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.3206]
[Page 422-423]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
Subpart D Medical Devices
Sec. 74.3206 D&C Green No. 6.
(a) Identity. The color additive D&C Green No. 6 shall conform in
identity to the requirements of Sec. 74.1206(a).
(b) Specifications. The color additive D&C Green No. 6 for use in
medical devices shall conform to the specifications of Sec. 74.1206(b).
(c) Uses and restrictions. (1) The color additive D&C Green No. 6
may be safely used at a level
(i) Not to exceed 0.03 percent by weight of the lens material for
coloring contact lenses;
(ii) Not to exceed 0.75 percent by weight of the suture material for
coloring polyethylene terephthalate surgical sutures, including sutures
for ophthalmic use;
[[Page 423]]
(iii) Not to exceed 0.1 percent by weight of the suture material for
coloring polyglycolic acid surgical sutures with diameter greater than
U.S.P. size 8-0, including sutures for ophthalmic use;
(iv) Not to exceed 0.5 percent by weight of the suture material for
coloring polyglycolic acid surgical sutures with diameter not greater
than U.S.P. size 8-0, including sutures for ophthalmic use;
(v) Not to exceed 0.21 percent by weight of the suture material for
coloring poly(glycolic acid-co-trimethylene carbonate) sutures (also
referred to as 1,4-dioxan-2,5-dione polymer with 1,3-dioxan-2-one) for
general surgical use; and
(vi) Not to exceed 0.10 percent by weight of the haptic material for
coloring polymethylmethacrylate support haptics of intraocular lenses.
(2) Authorization for these uses 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 with respect to the medical device
in which D&C Green No. 6 is used.
(d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(e) Certification. All batches of D&C Green No. 6 shall be certified
in accordance with regulations in part 80 of this chapter.
[48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51
FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993]
Back to Top
© 2007 Betterchem Corp.
|
