Guidance for Industry, FDA Staff, 
Eye Care Professionals, and 
Consumers
 
 
Decorative, Non-corrective 
Contact Lenses  
 
 
 
Document Issued on: November 24, 2006 
 
 
For questions regarding this document contact Ernest N. Smith, HFZ-331, 240-276-0115 or by 
email at ernest.smith@fda.hhs.gov.  
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Ophthalmic Devices Branch 
Division of Enforcement A 
     Office of Compliance 
 
    Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration 
to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be 
submitted to http://www.fda.gov/dockets/ecomments.  Please identify your comments with 
the docket number listed in the notice of availability that publishes in the Federal Register 
announcing the availability of this guidance document.  Comments may not be acted upon by 
the Agency until the document is next revised or updated.   
 
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/comp/guidance/1613.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
240-276-3151 to receive a hard copy.  Please use the document number 1613 to identify the 
guidance you are requesting.  
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry, FDA Staff, Eye 
Care Professionals, and Consumers 
 
Decorative, Non-corrective Contact Lenses  
 
  
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
Introduction  
 
On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic 
Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under 
section 201(h) of the Act.  Because all contact lenses are now regulated as devices, including 
decorative, non-corrective contact lenses intended only to change the normal appearance of 
the eye, all contact lenses must be the subject of a cleared premarket notification (510(k)) or 
an approved premarket approval application (PMA) before they may be legally marketed.    
Additional device authorities, such as the requirement that lenses be dispensed only upon a 
prescription order, also apply.  This guidance explains how section 520(n) affects FDAs 
regulation of non-corrective contact lenses intended to change the appearance or color of a 
normal eye for decorative use. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation.  This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
  1 Contains Nonbinding Recommendations 
 
requirements.  However, if you believe that an alternative approach would be less 
burdensome, please contact us so we can consider your point of view.  You may send your 
written comments to the contact person listed in the preface to this guidance or to the CDRH 
Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways to 
contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
 
I. Background 
 
FDA is aware of the distribution and use of non-corrective contact lenses that are used to 
change the normal appearance of the eye in a decorative fashion, such as with colors or 
designs (decorative contact lenses).  Decorative contact lenses that do not have FDA 
premarket authorization have been marketed directly to consumers.  Consumers have 
used such lenses without the benefit of a valid prescription.   
 
Without a valid prescription, fitting, supervision, or regular check-ups by a qualified eye 
care professional, decorative contact lenses, like all contact lenses, can cause a variety of 
serious injuries or conditions.  For example, lens wear has been associated with corneal 
ulcer, which can lead rapidly to internal ocular infection if left untreated.  Uncontrolled 
infection can cause corneal scarring, which can lead to vision impairment, and in extreme 
cases, blindness or the loss of an eye.  Other risks include conjunctivitis; corneal edema 
(swelling); allergic reaction; abrasion from poor lens fit; reduction in visual acuity, 
contrast sensitivity, and other visual complications that can interfere with driving and 
other activities.   
 
Because of these risks, contact lenses, including decorative contact lenses that are non-
corrective, are not safe for use except under the supervision of a practitioner licensed by 
law to direct the use of such devices.  The Agency believes that these risks cannot be 
sufficiently controlled unless the wearer does the following under professional 
supervision:   
 
  Obtains advice about using contact lenses; 
  Has a valid prescription; 
  Has the lenses fitted properly; and 
  Remains under appropriate professional care for contact lens use. 
 
 
 
II. How does recent legislation affect FDAs regulation 
of contact lenses?
 
 
FDA has reviewed premarket notification submissions (510(k)s) under section 510(k) of 
the Act  (21 U.S.C. 360(k)) and premarket approval applications (PMAs) under section 
515 of the Act (21 U.S.C. 360(e)) for most corrective and non-corrective contact lenses 
marketed in the United States, including certain decorative contact lenses intended to 
  2 Contains Nonbinding Recommendations 
 
change the appearance of a normal eye.  All currently approved or cleared decorative 
contact lenses are legally marketed only as prescription devices (21 CFR 801.109).  
However, some non-corrective, decorative contact lenses have not been reviewed by 
FDA and are sold without a prescription.  Although FDA had taken the position that 
contact lenses intended solely for decorative use may be regulated as cosmetics under 
section 201(i) of the Act, enactment of section 520(n) requires that all contact lenses be 
regulated as devices.   
 
Thus, all contact lenses in commercial distribution, including decorative contact lenses 
that are non-corrective, require either a cleared 510(k), an approved PMA, or an 
exemption for investigational use (IDE).  Without such premarket authorization by FDA, 
decorative contact lenses are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 
351(f)(1)(B)), and misbranded under section 502(o) of the Act (21 U.S.C. 352(o)). 
 
III. Can manufacturers, importers, distributors, or 
retailers market decorative contact lenses as over-the-
counter products? 
 
No.  Decorative contact lenses should not be marketed or made available to consumers by 
manufacturers, importers, distributors, or retailers as an over-the counter item.  
Manufacturers or initial importers should cease distribution of the devices and submit to 
FDA an appropriate premarket notification for clearance or application for approval if 
they intend to distribute any type of non-corrective contact lenses, including decorative 
lenses used to change the appearance of a normal eye.  Guidance for 510(k) submissions 
for contact lenses is located at http://www.fda.gov/cdrh/ode/conta.html.  Contact lenses, 
including decorative, non-corrective contact lenses, are also subject to general controls of 
the Act, including the Quality System regulation (21 Code of Federal Regulations (CFR) 
Part 820), and other applicable device regulations and statutory requirements, including 
conformance with labeling requirements such as 21 CFR 801.109.   
 
IV. Are manufacturers, importers, distributors, or 
retailers subject to inspection by FDA?
 
 
Yes.  FDA has inspected several firms distributing decorative contact lenses and warned 
firms that selling decorative contact lenses without a valid prescription or proper labeling 
that includes information about the risks and proper instructions for safe use violates 
federal law.  FDA has also alerted mass marketing firms and operators of on-line sites 
about the risks associated with decorative contact lenses distributed without appropriate 
eye care professional involvement.    
 
V. How are imported lenses affected by FDAs law? 
 
  3 Contains Nonbinding Recommendations 
 
As devices, imported decorative contact lenses that do not comply with applicable premarket 
device requirements are subject to detention without physical examination under the 
procedures described in FDAs Import Alert #89-08, Detention without Physical 
Examination of Devices without Approved PMAs or IDEs and Other Devices not 
Equivalent or no 510(k) (see also section 801 of the act, 21 U.S.C. 381).  The import alert 
instructs FDA personnel and officials of the United States Customs Service to detain 
automatically all devices presented at the United States ports of entry that are in violation of 
federal law. Import Alert #89-08, can be accessed on the Internet at: 
http://www.fda.gov/ora/fiars/ora_import_ia8908.html. 
 
VI. Can consumers still buy contact lenses used for 
decorative purposes only? 
 
Yes, if there is a valid prescription. As when buying all contact lens, consumers should 
be seen by an eye care professional and obtain proper fitting and instructions for using a 
contact lens.  These devices present significant risks of eye injuries, including blindness, 
if distributed without a valid prescription and the involvement of a qualified eye care 
professional and appropriate follow-up care.   
 
More information for consumers on the use of decorative lenses can be found on FDAs 
web site http://www.fda.gov/bbs/topics/NEWS/2003/NEW00955.html. 
 
 
  4