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 to 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 to 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 (21 
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  21 CFR  71, the applicant  may submit the infor- 
mation required under Part 71 as part of  the PMA.  As provided  by  21 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 21 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 21 CFR 71.  3.  Because all color additive petitions are 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 letter to minimize delays in forwarding by  CDRH of 
the color additive petition to CFSAN for processing. 
5.  A color additive petition included  in  a  PMA  is subject  to the confidentiality 
provisions of 21 CFR 71 rather than 21 CFR 814.