[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Proposed Rules]
[Pages 31164-31168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14653]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 99N-1309]


Obstetrical and Gynecological Devices; Proposed Classification of 
Female Condoms

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify the preamendments female condom intended for contraceptive and 
prophylactic purposes. Under this proposal, the preamendments female 
condom would be classified into class III (premarket approval). The 
agency is publishing in this document the March 7, 1989, 
recommendations of FDA's Obstetrics-Gynecology Devices Panel (the 
Panel) regarding the classification of this device. After considering 
public comments on this classification proposal, FDA will publish a 
final rule classifying this device. This action is being taken to 
establish regulatory controls that will provide reasonable assurance of 
the safety and effectiveness of this device.

DATES: Written comments by Septmeber 8, 1999. See section IV of this 
document for the proposed effective date of a final rule based on this 
document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit written requests for single copies on a 
3.5'' diskette of the draft guidance entitled ``Premarket Testing 
Guidelines for Female Barrier Contraceptive Devices Also Intended to 
Prevent Sexually Transmitted Diseases, April 4, 1990'' to the Division 
of Small Manufacturers Assistance (DSMA) (HFZ-220), Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 401-443-8818. In order to receive this draft guidance via 
your fax machine, call the CDRH Facts-On-Demand (FOD) System at 800-
899-0381 or 301-827-0111 from a touch-tone-telephone. At the first 
voice prompt press 1 to access DSMA Facts, at second voice prompt press 
2, and then enter the document number (384) followed by the pound sign 
(#). Follow the remaining voice prompts to complete your request.
FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION:

I. Background

A. Classification of Medical Devices

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the 
SMDA) (Pub. L. 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (the FDAMA) (Pub. L. 105-115), established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) established three 
categories (classes) of devices, depending on the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendations for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by the FDAMA; or (3) FDA issues an order finding 
the device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously offered devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final rule under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Consistent with the act and regulations, FDA consulted with the 
Obstetrical and Gynecological Device Classification Panel regarding the 
classification of this device. This panel was subsequently terminated, 
rechartered, and renamed the Obstetrics-Gynecology Devices Panel (the 
Panel).

B. Regulatory History of Female Condoms

    In the Federal Register of April 3, 1979 (44 FR 19894), FDA 
published a proposed rule classifying all known obstetrical and 
gynecological preamendments devices, including condoms. The proposed 
rule described the methods used by the agency to identify such 
preamendments devices, e.g., FDA's 1972 survey of device manufacturers, 
FDA's searches of published literature, and the activities of the 
Panel. Subsequently, in the

[[Page 31165]]

Federal Register of February 26, 1980 (45 FR 12710), FDA published a 
final rule classifying certain obstetrical and gynecological 
preamendments devices, including classifying the condom into class II 
(Sec. 884.5300 (21 CFR 884.5300)). The condom encompasses preamendments 
barrier-type sheaths that cover the entire shaft of the penis for 
purposes of contraception (preventing pregnancy), prophylaxis 
(preventing transmission of sexually transmitted diseases (STD's)), or 
semen collection (diagnostic testing). Preamendments devices 
characteristically falling within this classification are generally 
referred to as condoms.
    Following classification of the condom into class II, FDA received 
two 510(k) notifications for ``female condoms'' intended to be inserted 
into the vagina and held in place to line the vaginal walls for 
purposes of contraception and prophylaxis. These 510(k) notifications 
claimed substantial equivalency to the condom identified in 
Sec. 884.5300. Initially, in late 1987, in response to a 510(k) 
notification submitted by the Energy Basin Clinic to market a ``barrier 
female condom,'' FDA concurred that this condom, later called the 
Bikini Condom, was substantially equivalent to the class II condom 
(Ref. 1). Subsequently, in 1989, the agency received a 510(k) 
notification from the Wisconsin Pharmacal Co. for the WPC-333 female 
use condom-like device (WPC-333 device), later called the Femshield/
Reality (Intra-) Vaginal Pouch and Reality Female Condom. This 510(k) 
submission brought new information to the agency's attention concerning 
the existence of a preamendments female use condom-like device.
    The Wisconsin Pharmacal Co. claimed in its 510(k) notification that 
its WPC-333 device was substantially equivalent to the condom 
identified in Sec. 884.5300 as well as to another preamendments device 
known as the Gee Bee Ring. Documentation in the 510(k) notification 
indicated that the Gee Bee Ring was a double-ringed pouch-type 
preamendments device intended for insertion into the vagina to line the 
walls of the vagina for contraceptive (pregnancy prevention) and 
prophylactic (prevention of STD's transmission) purposes (Ref. 2).
    Upon receiving this information, FDA verified the existence, 
commercial distribution, and uses of the Gee Bee Ring, as best it 
could, through an affidavit and review of a May 1934 booklet printed 
contemporaneously with the distribution of the product (Refs. 2 and 3). 
The booklet entitled A New Method for the Profession, states on page 
12, ``[T]he technique with this method (the modified Gee Bee technique) 
has a factor of safety equal to, if not better than, the diaphragm. It 
overcomes all the objections to the rubber condom * * *.'' These 
statements are taken by the agency to mean that the device was 
indicated as a contraceptive product (by reference to the diaphragm), 
and as a prophylactic product (by reference to the condom, which at 
that time (1934) was solely indicated as a prophylactic, i.e., for 
preventing the transmission of sexually related diseases). 
Subsequently, the agency presented this Gee Bee Ring information to the 
Panel as new information about a preamendments device not previously 
known to the agency.
    During an open meeting held on March 7, 1989, (Ref. 14) the Panel 
reviewed all available information concerning the classification of a 
barrier-type pouch device that is inserted into the vagina prior to 
coitus and lines the vaginal wall and external cervix. Such available 
information indicated that the preamendments device, known as the Gee 
Bee Ring, was distributed, beginning in the 1930's and for some years 
thereafter, as a female condom, i.e., as a ``modified condom placed in 
the hands of the female * * * for proper insertion and use.'' (See Ref. 
2.) The Panel determined that this particular device represented a 
generic type of preamendments device that the Panel identified as the 
vaginal pouch, rather than the condom, noting that the classification 
regulation for the condom device (Sec. 884.5300) identifies the condom 
as ``a sheath which completely covers the penis with a closely fitting 
membrane'' (emphasis added). The regulation also states that the condom 
is used ``for contraceptive and for prophylactic purposes (preventing 
transmission of sexually transmitted disease)'' and ``to collect semen 
to aid in the diagnosis of infertility.'' Because an intravaginal pouch 
loosely lines the interior of the vagina, rather than closely fitting 
the penis, and because there is no data to establish the safe and 
effective use of the intravaginal pouch, the Panel recommended that FDA 
not include the intravaginal pouch in the condom classification 
(Sec. 884.5300), but classify this generic type of device as a device 
that is distinct from condoms.
    Subsequently, in April 1989, in response to the Wisconsin Pharmacal 
Co. 510(k), FDA advised the firm that its WPC-333 device is not 
substantially equivalent to either the condom identified in 
Sec. 884.5300 or the Gee Bee Ring, due to design differences. As a 
result, in accordance with section 513(f) of the act, the device was 
automatically classified into class III (Ref. 4). In April 1989, FDA 
also advised the Energy Basin Clinic that the agency's response to the 
firm's 510(k) was incorrect, in that the firm's ``barrier female 
condom'' is not substantially equivalent to the condom as defined in 
Sec. 884.5300 and that commercial marketing would misbrand the device 
under section 502(f) and (o) of the act (21 U.S.C. 352(f) and (o)) 
(Ref. 5).
    During an August 25, 1989, open Panel meeting, FDA, the Panel, 
other Federal health agency experts, and interested parties discussed 
premarket testing requirements for female barrier contraceptives that 
also claim prevention of STD's transmission. Currently, postamendments 
female condoms are classified automatically by statute (section 513(f) 
of the act) into class III and in the Federal Register of June 7, 1990 
(55 FR 23299), FDA has made available draft guidance describing the 
studies needed to support a PMA application for female condoms that 
also claim to prevent STD's (Ref. 6). This draft guidance describes the 
preclinical, clinical feasibility, and clinical safety and 
effectiveness studies needed to expedite the study and evaluation of 
PMA's for female condom devices that also claim prevention of STD's 
transmission. See the ADDRESSES section of this document for the 
guidance's availability.
    On August 29, 1990, FDA responded to another 510(k) notification 
for a ``female condom'' which was submitted by MD Personal Products, 
Inc. (hereinafter referred to as MD Products). In response to the 
510(k), FDA advised MD Products that its pouch-type device intended to 
line the vagina is not substantially equivalent to either the condom 
identified in Sec. 884.5300 or the Gee Bee Ring, due to differences in 
technological characteristics and design (Ref. 7).
    On May 29, 1993, FDA approved the PMA for the Wisconsin Pharmacal 
Co. ``Reality'' Female Condom (Ref. 8).

II. Recommendations of the Panel

    During a public meeting held on March 7, 1989, the Panel made the 
following recommendations with respect to the classification of the 
intravaginal pouch:

A. Identification

    The Panel recommended that the device be identified as follows: An 
intravaginal pouch is a sheath-like device that lines the vaginal wall 
and is inserted into the vagina prior to the initiation of coitus. It 
is indicated for

[[Page 31166]]

contraceptive and prophylactic (preventing the transmission of STD's) 
purposes.
    The Panel cautioned against the use of the term condom in the 
generic type of device because a condom is defined as ``a sheath which 
completely covers the penis with a closely fitting membrane,'' and use 
of the term to identify this generic type of device may be 
misunderstood by some persons to suggest that products in this group 
have the same performance characteristics as traditional full-sheath 
male condoms.

B. Recommended Classification of the Panel

    The Panel recommended that the intravaginal pouch be classified 
into class III (premarket approval). The Panel unanimously recommended 
assigning a high priority to premarket approval because of the absence 
of testing and clinical medical data regarding the safety and 
effectiveness of the device and because device failure could result in 
release of semen into the vagina leading to unwanted pregnancies and 
transmission of disease, such as acquired immune deficiency syndrome 
(AIDS) caused by the human immunodeficiency virus (HIV) from HIV-
infected semen. For women for whom pregnancy is contraindicated due to 
medical conditions such as heart disease or diabetes mellitus, the risk 
of an unwanted pregnancy can be severe, even life threatening.

C. Summary of Reasons for Recommendation

    After reviewing the information provided by FDA, and after 
consideration of the open discussions during the Panel meeting and the 
Panel members' personal knowledge of and clinical experience with the 
device system, the Panel gave the following reasons in support of its 
recommendation to classify the intravaginal pouch into class III.
    The Panel recommended that the intravaginal pouch be classified 
into class III because no published laboratory or clinical study data 
could be found that demonstrate the safety and effectiveness of the 
device. Reference to this type of device in past literature is limited 
(Ref. 2). More recent literature affirms the preliminary nature of 
certain studies; the need for in vitro and in vivo preclinical studies, 
including permeability studies of the device materials with respect to 
bacterial and viral STD-causing organisms; and the need for 
microbiological and clinical data that demonstrate the safety and 
contraceptive and prophylactic efficacy of this generic type of device 
(Ref. 9).
    The Panel believed that the intravaginal pouch should be classified 
into class III because general controls and special controls would not 
provide reasonable assurance of the safety and effectiveness of the 
device, and the device is purported or represented to be for a use in 
supporting or sustaining human life or for a use which is of 
substantial importance in preventing impairment of human health, or 
presents a potential unreasonable risk of illness or injury. Although 
the safety of some device characteristics, such as the biocompatibility 
of device substances contacting the body, could be controlled through 
materials tests and specifications, the Panel believes there is 
insufficient evidence that a performance standard could be established 
to provide reasonable assurance of the safe and effective performance 
of the device. For example, no valid scientific evidence demonstrates 
whether, how often, or to what degree, the intravaginal pouch dislodges 
or becomes displaced during intercourse.

D. Summary of Data on Which the Recommendation is Based

    The Panel based its recommendation on information provided by FDA, 
data and information contained in references 2 and 9, and on the Panel 
members' personal knowledge of, and experience with, contraceptive 
methods of birth control, including barrier-type contraceptives. 
Additionally, the Panel found no data in the literature or in studies 
discussed before the Panel to support the safety and effectiveness of 
the devices.
    The Panel noted that failure of intravaginal pouches because of 
breakage, leakage, dislodgement, or displacement that leads to the 
release of semen, could result not only in undesired pregnancies, but 
also in the transmission of STD's, such as AIDS. Therefore, the Panel 
recommended that the labeling of these devices contain use 
effectiveness information, particularly, pregnancy rate information, 
and adequate indications and directions for use. The Panel believed 
that the device must be subject to premarket approval to assure that 
manufacturers demonstrate the satisfactory performance of the device 
for its intended use or uses, thereby providing reasonable assurance of 
its safety and effectiveness.

E. Risks to Health

    The Panel identified the following risks to health associated with 
use of the device:
    1. Pregnancy
     Leakage, breakage, dislodgement, or displacement of the device 
during sexual intercourse could result in the occurrence of an 
undesired pregnancy.
    2. Disease Transmission
     If the device fails due to leakage, breakage, dislodgement, or 
displacement, contact with infected semen or vaginal secretions or 
mucosa could result in the transmission of STD's, including HIV 
(causing AIDS).
    3. Adverse Tissue Reaction
    Unless the biocompatibility of materials and substances comprising 
the device are tested, local tissue irritation, and sensitization or 
systemic toxicity could occur when the vaginal pouch contacts the 
vaginal wall and cervical mucosa, and the penis.
    4. Ulceration and Other Physical Trauma

III. Proposed Classification

    On its own initiative, FDA is proposing to change the name of the 
generic type of device identified by the Panel from ``intravaginal 
pouch'' to ``female condom.'' FDA agrees with the Panel's finding that 
the female condom represents a type of preamendments device that has 
different technological characteristics than the preamendments condom 
identified in Sec. 884.5300 and concurs with the Panel's recommendation 
that the female condom not be considered a type of device that falls 
within the classification category of condom (Sec. 884.5300).
    FDA believes that the proposed name, ``female condom,'' better 
connotes the intended female use and purposes of the device than does 
the term, ``intravaginal pouch,'' i.e., female usage of the pouch-like 
device to line the vaginal walls for purposes of preventing pregnancy 
and STD's transmission. Adequate labeling for female condoms, including 
adequate directions for use, and actual usage by female users will make 
clear to sexual partners the differences between female condoms and 
male condoms.
    FDA disagrees with the Panel's concern that the use of the term 
``condom'' to describe or make reference to the female condom may imply 
that the female condom will have the same contraceptive and 
prophylactic effectiveness as a condom, as defined in Sec. 884.5300, in 
preventing undesired pregnancy and protecting against STD's, including 
AIDS. The agency believes any such misconception can be dispelled by 
requiring that the labeling of the female condom device clearly and 
adequately state the contraceptive failure rates pertinent to any 
claims made for preventing undesired pregnancy and adequately describe 
clinical effectiveness data, including

[[Page 31167]]

pertinent information on the impermeability of the device to sexually 
transmitted viral or bacterial disease, associated with any 
prophylactic claims for protection against STD's, including AIDS.
    FDA notes that differences in technological characteristics and 
design among devices within the same generic type of device may raise 
new questions of safety and effectiveness that prevent the devices from 
being substantially equivalent to one another. Such was the case for 
the 510(k) notifications for certain postamendments female condoms 
claiming substantial equivalence to the preamendments female condom, 
the Gee Bee Ring. In the preamble of the final rule setting forth 
classification procedures (43 FR 32988 at 32989, July 28, 1978), FDA 
noted that ``The term `generic type of device' describes FDA's 
grouping, for reasons of administrative convenience, of devices that 
are to be regulated in the same way because they present similar safety 
and effectiveness concerns. A generic type of device will include 
devices that may or may not be `within a type' and `substantially 
equivalent' to each other.'' (Emphasis added.)
    FDA believes the female condom should be classified into class III 
because general controls and special controls would not provide 
reasonable assurance of the safety and effectiveness of the device and 
the device is purported or represented to be for a use in supporting or 
sustaining human life or for a use which is of substantial importance 
in preventing impairment of human health, or presents a potential 
unreasonable risk of illness or injury. FDA believes that the calling 
for PMA's for this device should be a high priority.
    FDA agrees with the Panel's conclusions and recommendations 
regarding the unproven contraceptive effectiveness of the preamendments 
female condom and its indeterminate efficacy in protecting against the 
transmission of STD's. The agency has neither received nor found in the 
literature valid scientific evidence from laboratory tests, preclinical 
studies, or clinical investigations that does the following: (1) 
Demonstrates the biocompatibility of materials used in the 
preamendments female condom; (2) measures performance characteristics, 
such as displacement, dislodgement, bursting, and tearing; (3) assesses 
the contraceptive safety and effectiveness of the preamendments device 
in preventing pregnancy, in terms of reported failure or pregnancy 
rates based upon usage (Refs. 2, 9, and 10); or (4) demonstrates the 
prophylactic efficacy of the preamendments device in protecting against 
the transmission of STD's, including HIV (Refs. 10 through 13). The 
agency believes that the present voluntary industry standard and the 
agency's methodology for testing conventional condoms for pinhole leaks 
are not suitable for testing the female condom for leaks without 
significant modification and validation.
    FDA notes that the labeling of certain marketed barrier 
contraceptive devices, such as the contraceptive diaphragm and 
accessories (21 CFR 884.5350), and the cervical cap (21 CFR 884.5250), 
identify pregnancy rates associated with the use of the devices. The 
expected failure or pregnancy rates for use of the conventional full-
sheath condom are widely published. Such information is not available 
for the preamendments female condom device. Consequently, the agency 
agrees with the Panel that pregnancy rate information, derived from 
valid clinical study data, should be included in female condom 
labeling. Otherwise, the labels would fail to disclose a material fact 
regarding the consequences which may result from using the female 
condom.

IV. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after its date of publication in the 
Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4)). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the proposed rule is not a significant regulatory 
action as defined by the Executive Order and so it is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. FDA believes that there is likely no interest at 
this time in marketing the device to be classified by this rule. FDA is 
taking this action because it has determined that premarket approval is 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device, if there is any interest in marketing one 
in the future. Without this rule (and a subsequent requirement for 
PMA's), a person could market a device by claiming substantial 
equivalence to the Gee Bee Ring. All premarket submissions for ``female 
condom'' type devices that FDA has received to date have been for 
devices that have been found to be not substantially equivalent to the 
Gee Bee Ring and, therefore, those devices are not preamendments 
devices and are not to be classified by this rule. If a final rule is 
issued classifying these devices in class III, FDA would be required to 
undertake subsequent notice and comment rulemaking to establish an 
effective date by which PMA's would be required for this device. Under 
section 501(f)(2)(B) of the act (21 U.S.C. 351(f)(2)(B)), a rule 
requiring PMA's for this device could not take effect any sooner than 
30 months after the effective date of a final rule classifying the 
device or 90 days after publication of the final rule requiring the 
PMA's, whichever is later.
    The agency therefore certifies that this proposed rule, if issued, 
will not have a significant economic impact on a substantial number of 
small entities. In addition, this proposed rule will not impose costs 
of $100 million or more on either the private sector or State, local, 
and tribal governments in the aggregate, and therefore a summary 
statement or analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule requires no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VIII. Submission of Comments

    Interested persons may, on or before September 8, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments

[[Page 31168]]

are to be submitted except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter from the Office of Device Evaluation, CDRH, FDA, to 
the Energy Basin Clinic regarding substantially equivalent 
determination for the Barrier Condom, August 3, 1987.
    2. Beadle, E. L., ``A New Method for the Profession: Outline of 
Successful Prophylactic Program,'' The Hemingway Press, Waterbury, 
CN, 1934.
    3. Affidavit from Richard Beadle to FDA regarding the Gee Bee 
Ring, its labeling, and its distribution, July 17, 1989.
    4. Letter from the Office of Device Evaluation, CDRH, FDA, to 
the Wisconsin Pharmacal Co. regarding the not substantially 
equivalent determination for the WPC-333 Vaginal or Female Condom, 
April 14, 1989.
    5. Letter from the Office of Device Evaluation, CDRH, FDA, to 
the Energy Basin Clinic regarding the not substantially equivalent 
determination for the Barrier Condom, April 26, 1989.
    6. CDRH, FDA guidance document entitled ``Premarket Testing 
Guidelines for Female Barrier Contraceptive Devices Also Intended to 
Prevent Sexually Transmitted Diseases,'' April 4, 1990.
    7. Letter from the Office of Device Evaluation, CDRH, FDA, to MD 
Personal Products, Inc., regarding the not substantially equivalent 
determination for the Women's Choice Brand Condom,'' August 29, 
1990.
    8. Letter from the Office of Device Evaluation, CDRH, FDA, to 
the Wisconsin Pharmacal Co. regarding PMA approval for the 
``Reality'' Female Condom, May 7, 1993.
    9. Bounds, W., J. Guillebaud, L. Stewart, and S. Steele, ``A 
Female Condom (FemshieldTM); A Study of its User-
Acceptability,'' British Journal of Family Planning, 14:83, 1988.
    10. Bounds, W., ``Male and Female Condoms,'' British Journal of 
Family Planning, 15:14, 1989.
    11. Connell, E. B., ``Barrier Contraceptives,'' Clinical 
Obstetrics and Gynecology, 32:377, 1989.
    12. Harris, J. R., L. W. Kanagas, and J. D. Shelton, ``Role of 
Condoms in Preventing HIV Transmission in Developing Countries,'' 
Heterosexual Transmission of AIDS, ch. 32, p. 399, Alan R. Liss, 
Inc., 1990.
    13. Gregersen, E., and B. Gregersen, ``The Female Condom--A 
Pilot Study of the Acceptability of a New Female Barrier Method,'' 
Acta Obstetricia ET Gynecologica Scan, 69:73, 1990.
    14. Obstetrics-Gynecology Devices Panel, transcript and meeting 
minutes, March 7, 1989.

List of Subjects in 21 CFR Part 884

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 884 be amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    1. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 884.5330 is added to subpart F to read as follows:

Sec. 884.5330  Female condom.

    (a) Identification. A female condom is a sheath-like device that 
lines the vaginal wall and is inserted into the vagina prior to the 
initiation of coitus. It is indicated for contraceptive and 
prophylactic (preventing the transmission of sexually transmitted 
diseases) purposes.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. No 
effective date has been established of the requirement for premarket 
approval for the devices described in paragraph (b) of this section. 
See Sec. 884.3 for effective dates of requirement for premarket 
approval.

    Dated: May 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-14653 Filed 6-9-99; 8:45 am]
BILLING CODE 4160-01-F