Guidance for Industry
Uniform Contraceptive Labeling
Document issued on:  July 23, 1998
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Obstetrics and Gynecology Devices Branch
Division of Reproductive, Abdominal, Ear, Nose and Throat,
and Radiological Devices
Office of Device Evaluation Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration
to Colin Pollard, HFZ-470, Obstetrics and Gynecology Devices Branch, Office of
Device Evaluation, FDA, 9200 Corporate Boulevard, Rockville, Maryland, 20850.
Comments may not be acted upon by the Agency until the document is next
revised or updated.  For questions regarding the use or interpretation of this
guidance contact Colin Pollard at 240 276-4155 or colin.pollard@fda.hhs.gov.
Additional Copies
World Wide Web/CDRH  home page:  http://www.fda.gov/cdrh or CDRH Facts
on Demand at 1-800-899-0381 or 301-827-0111, specify number 1251 when
prompted for the document shelf number. Uniform Labeling for Contraceptive Devices:
Guidance to Industry
Background
This guidance provides agency recommendations for the labeling of all contraceptive
devices regarding protection from pregnancy and sexually transmitted diseases.  Much of
this information has already been transmitted over the years to the industry in a variety of
letters and guidance documents.  This guidance document is an effort to bring all of these
previous recommendations together into one document that will serve to encourage a
uniform approach to this type of labeling information for the consumer.  Where
appropriate, this same information should be included in the professional labeling for these
devices.  It should be noted that these recommendations are the result of an intra-agency
effort that involved CDRHs Office of Device Evaluation and Office of Health and
Industry Programs (OHIP), as well as the Division of Reproductive and Urologic Drug
Products and the Division of Over-the-Counter Drug Products in the Center for Drug
Evaluation and Research.  The effort was overseen by FDAs Office of Womens Health,
which also provided funding for focus studies conducted by OHIP.
Protection from Pregnancy
Labeling for all contraceptive devices (including male & female condoms, diaphragms,
cervical caps, intrauterine devices (IUDs), and tubal occlusion devices (TODs) should
contain an easy-to-read table with the pregnancy rates associated with all methods.  This
table is intended to provide the device user with pregnancy rate on his/her selected
contraceptive, as well as comparative information on the pregnancy rates of various other
contraceptive products.  The table recommended by FDA uses pregnancy rates based on
data from Trussell, et al, from the 17th edition of Contraceptive Technology (1997).  Using
information from a series of focus studies conducted by the CDRH, FDA developed a
re-formatted table (copy attached) that contains the appropriate information in an
understandable form to help people appreciate the effectiveness of their contraceptive of
choice with respect to the many other products available on the market.
FDA considers the communication of information on pregnancy rates to users of
contraceptive devices to be essential for their safe and effective use.  Therefore, all
contraceptive devices should have labeling with a table like the one recommended in this
guidance document.  In addition, for those products requiring professional labeling, the
same table should be included in an appropriate section of that labeling. Protection from Sexually Transmitted Diseases (STDS)
In addition to inclusion of a contraceptive efficacy table in the labeling, manufacturers
should include information to the user on the ability of that contraceptive device to
provide protection from STDs.  FDA has requested that manufacturers, depending on the
type of contraceptive device, include one of the following statements in their
patient/consumer labeling regarding transmission of STDs.
For intrauterine devices (IUDs), tubal occlusion devices, and natural skin condoms:
This product is intended to prevent pregnancy.  It
does not protect against HIV infection and other
sexually transmitted diseases.
For natural skin condoms, the following additional statement should be included:
In order to help reduce the risk of transmission of
many STDs, including HIV infections (AIDS), use a
latex condom.
For latex condoms for men:
(On the condom wrapper/Principal display panel)
If used properly, latex condoms will help to reduce
the risk of transmission of HIV infection (AIDS) and
many sexually transmitted diseases.
(Directions For Use)
If used properly, latex condoms will help to reduce
the risk of transmission of HIV infection (AIDS) and
many sexually transmitted diseases, including
chlamydia, genital herpes, genital warts,
gonorrhea, hepatitis B, and syphilis. For male condoms made from new materials:
This interim labeling is based on slippage & breakage data while a contraceptive
effectiveness study is underway.
You may use this [insert name] condom if you or
your partner are allergic to latex.
You should know:
  The risks of pregnancy and sexually transmitted
diseases (STDs), including AIDS (HIV
infection), are not known for this condom.  A
study is being done.
  There are laboratory tests on this [blank]
material.  These tests show that organisms even
as small as  sperm and viruses like HIV cannot
pass through it.
Latex condoms [boldface] for men, if used correctly
with every act of vaginal intercourse, are highly
effective at preventing pregnancy, as well as STDs,
including AIDS (HIV infection).
For female condoms, the following key elements are placed on the primary package
as well as the package insert:
  Latex condoms for men are highly effective at
preventing sexually transmitted diseases, including
AIDS (HIV infection), if used properly.
  If you are not going to use a male latex condom, you
can use [insert name] to help protect yourself and your
partner.
  [Insert name] only works when you use it.  Use it every
time you have sex.
  Before you try [insert name], be sure to read the
directions in the box and learn how to use it properly. For diaphragms and cervical caps:
FDA is aware of a few clinical studies of diaphragms and vaginal spermicides that look at
protection from a few STDs.  However, these studies are not conclusive, and no definitive
statement that can be used for uniform labeling has been developed.  Therefore, no claims
for STD protection afforded by diaphragms or cervical caps may be made without
submission of an appropriate 510(k) premarket notification or PMA supplement.
References
1)  Memorandum to FDAs Acting Director, Office of Womens Health, May 27, 1997,
on Uniform Contraceptive Effectiveness Labeling - Completion of Project.
 
2)  Silberberg, Paula, September 1996, Report On Four Focus Groups Among Women
On Their Reactions To Two Contraceptive Efficacy Table For Uniform Labeling,
Office of Health and Industry Programs, Center for Devices and Radiological Health.
 
3)  Hatcher et al., Contraceptive Technology, 17th ed., 1997, Irvington Publishers, Inc. Pregnancy Rates for Birth Control Methods
(For One Year of Use)
The following table provides estimates of the percent of women likely to become pregnant while using a
particular contraceptive method for one year. These estimates are based on a variety of studies.
"Typical Use" rates mean that the method either was not always used correctly or was not used with every
act of sexual intercourse (e.g., sometimes forgot to take a birth control pill as directed and became
pregnant), or was used correctly but failed anyway.
"Lowest Expected" rates mean that the method was always used correctly with every act of sexual
intercourse but failed anyway (e.g., always took a birth control pill as directed but still became pregnant).
Typical Use Lowest Expected
Method  Rate of Pregnancy Rate of Pregnancy
Sterilization:
Male Sterilization 0.15% 0.1%
Female Sterilization 0.5% 0.5%
Hormonal Methods:
Implant (Norplant(cid:228) and Norplant(cid:228)-2) 0.05% 0.05%
Hormone Shot (Depo-Provera(cid:228)) 0.3% 0.3%
Combined Pill (Estrogen/Progestin) 5% 0.1%
Minipill (Progestin only) 5% 0.5%
Intrauterine Devices (IUDs):
Copper T 0.8% 0.6%
Progesterone T 2% 1.5%
Barrier Methods:
Male Latex Condom 1 14% 3%
Diaphragm 2 20% 6%
Vaginal Sponge (no previous births) 3 20% 9%
Vaginal Sponge (previous births) 3 40% 20%
Cervical Cap (no previous births) 2 20% 9%
Cervical Cap (previous births) 2 40% 26%
Female Condom 21% 5%
Spermicide: (gel, foam, suppository, film) 26% 6%
Natural Methods:
Withdrawal 19% 4%
Natural Family Planning 25% 1-9%
(calendar, temperature, cervical mucus)
No Method: 85% 85%
1
  Used Without Spermicide
2
  Used With Spermicide
3
  Contains Spermicide
Data adapted from: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology:
Seventeenth Revised Edition. New York, NY: Ardent Media, 1998.
Table prepared by FDA:  5/13/97, revised 9/17/98