Color Additive Petitions - Medical Devices

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

This guidance was written prior to the February 27, 1997 implementation of FDA's
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elemnts of GGP's.

COLOR ADDITIVE PETITIONS
A color additive for use in or on a medical device is subject t o the requirements of
section 706 of the Federal Food, Drug, and Cosmetic Act if the color additive comes in
direct contact with the human body for a significant period 	of 	time. 	Because the
Medical Device Amendments of 	1976 lack guidance in determining whether there is
direct 	contact 	for 	a 	significant 	period 	of 	time, 	the 	applicant 	should 	contact 	the
Premarket Approval Staff for assistance in determining whether the use of the color
additive is subject to the requirements of section 706. 	FDA has determined that color
additives used in tinted soft contact lenses, dyed absorbable and nonabsorbable surgical
sutures, and bone cements are subject t o the requirements of section 706.
The term "color additive" means a material which (1) is a dye, pigment, or other
substance made by a process of synthesis or similar artifice, or extracted, isolated or
otherwise derivGd, with or without 	intermediate or final change of 	identity from a
vegetable, animal, mineral, or other source and (2) when added or applied to a [medical
device] or to the human body or any part thereof is capable (alone or through reaction
with other substance) of imparting color thereto. 	The term "color additive" does not
include any material which FDA determines is used (or intended to be used) solely for a
purpose or purposes other than coloring.
A color additive subject to section 706 of the act is considered unsafe (adulterated)
unless the color additive is listed for the appropriate use in accordance with section 706
of the act. 	The listing regulation may permit unqualified use of the color additive in a
generic type of device (e.g., contact lenses) or may place various limitations on its use
(e.g., 	polypropylene nonabsorbable sutures for general but not ophthalmic surgical use).
The color additive must be from a batch certified in accordance with regulations issued
under section 706(c) for that use, unless the color additive has been exempted from the
certification requirement. 	The investigational device exemption (IDE) regulations ( 2 1
CFR Parts 812 and 813) include provisions for exempting from the requirements of
section 706 a color additive or any specific use of the color additive when intended
solely for investigational use by qualified experts and such exemption is consistent with
the public health.
If a color additive subject to section 706 is used in or on a device subject to pre-
market approval and it has not previously been listed for such use, in lieu of submitting
a color additive petition (CAP) under 2 1 CFR 71, the applicant may submit the infor-
mation required under Part 71 as part of the PMA. 	As provided by 2 1 CFR 814.20(f),
when submitted as part of the PMA the information must be submitted in three copies,
each bound in one or more numbered volumes of reasonable size.
The applicant is cautioned that a PMA for a device that contains a color additive
subject to section 706 will not be approved until the color additive is listed for use in or
on the device. 	Regulations listing color additives for use in medical devices are codified
under 21 CFR 73 (Subpart D) if exempt from certification and 2 1 CFR 74 (Subpart D) if
subject to certification.
To assist in developing an appropriate strategy 	for submitting a color additive
petition, the PMA applicant is advised to consider the following:
1. 	The review period for a color additive petition may be as long as, and may
extend beyond, that for a PMA.
2. 	A color additive petition included in a PMA will be processed in accordance with
the procedures and fee schedules in 2 1 CFR 71.

3. 	Because all color additive petitions a r e processed by the FDA Center for Food
Safety and Applied Nutrition (CFSAN), processing of the color additive petition
will be delayed if it cross references rather than includes required information
in the remaining portion of the PMA reviewed by CDRH.
4. 	The existence of a color additive petition included in a PMA should be high-
lighted in the PMA cover l e t t e r t o minimize delays in forwarding by CDRH of
the color additive petition t o CFSAN for processing.
5. 	A color additive petition included in a PMA is subject t o the confidentiality
provisions of 2 1 CFR 71 rather than 2 1 CFR 814.