* "Janesway" is now at a new URL/site on the web. See:

http://www.janesway.net/

And especially: http://janesway.org/p+p

I'd asked my Congressional Representative, The Honorable Peter DeFazio, to plant some dynamite under the FDA (which sat on this AIDS preventive device for 15 years), but then a Silk Parasol Corporation representative asked me to back off --delicate negotiations and such. I pulled this web page for 3 years.

Now (6/04/05) I see no evidence that anyone is working on developing this device in these United States, the link at Janesway to Silk Parasol is a dead-end and traces of activity overseas indicate that a similar device has done poorly. Hopefully, the re-appearance of this web page won't any longer jeopardize patent claims or investment capitol.

Craig

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~The rest of this was last revised in 2002.

Note: I have no financial interest nor do I make any claim to intelectual property rights in the Janesway device or anything similar to it. Anyone who wishes to develop such a female condom is welcome to whatever credit and income it can produce.
 
 

Okay: it's time for me to sum up these 22 years of experience:

We've needlessly lost two decades during which (fill in the blanks) the lives of ___ women would have been saved, ___ unwanted pregnancies prevented, ___ couples allowed peace of mind and sexual delight.

Why?! --And what did I do wrong or fail to do right?

Here, from the scores of entities I've contacted, are some of the responses:

* One of my first letters to anyone went to a Dr. Zatuchni, Director, Program for Applied Research on Fertility Regulation, Northwestern University Medical School (11/24/80). There was no response, nor to a subsequent letter in 1993.

* My first letter to Planned Parenthood of Minnesota was sent to their Hamm Building address on 2/28/81. (National PPA finally responded to a letter of mine in 1999.)

* Lloyd L. Morain, Editor of The Humanist, responded with personal interest and suggestions (9/3/87).

* George Gori, VP for New Products Planning, Schmid, Laboratories, Inc.: "We -- decided not to pursue it at this time" (12/1/87).

* Department of Health & Human Services, FDA, advised of a flock of paper work if I wanted to produce it (4/1/88).

* The Bush Foundation. Responded with a form letter sent on the mis-assumption that I was trying to get a grant: "No" (7/12/89).

* The Ford Foundation. They read my letter, but also mis-assumed I wanted money: "No" (7/5/89).

* U. S. Representative Patricia Schroeder sent me a kind letter (8/30/89), but objected that "already too much of the responsibility of using birth control has been forced upon women"! (This was also the tenor of a women's group who protested the Bikini Condom idea in California [I think --only caught a blurb about it on the radio] about that time.) (I thought the woman's movement was about "empowerment". Silly me.)

* The San Francisco Foundation. Responded with encouragement, but added: "we don't have the contacts to help you" (6/28/89).

* U. S. Representative Timothy J. Penny --suggested I go to the NIH and the ICHHD (8/9/89).

* World Health Organization. "We're not in a position to give advice or other assistance" (7/7/89).

* Dr. Dale E. Hammerschmidt, Senior Editor, Journal of Laboratory and Clinical Medicine. (Dale is an organizational friend who briefly responded to my question about priority in a personal note.) It was his recollection that there'd been talk of a "female condom" sometime between 1972 and 1974, but couldn't remember if it had been in reference to serious efforts or merely ribald jokes among interns. (2/2/92).

* Dr. Lillian Yin, FDA -in response to my hammering them about holding up the Bikini Condom (per Reddy Health Care's laments to me --which see) in June of 1993. I'd copied my letter to the White House and everyone short of God :-)

She responded that it was actually Reddy Health Care/International Prophylactics who'd dropped the ball. The FDA determined that Reddy's earlier field tests were no longer valid (due to product modifications) and had to resubmit (6/25/93). I wrote back to Reddy Health Care on 7/1/93, suggesting that there might be some unawareness of what the FDA required of them, copying Dr. Yin.

* Dr. Lillian Yin, FDA --again (8/2/93) thanked me for my follow-up, but assured me that they'd on several occasions clearly delineated to Reddy Health the requirements for gaining market approval. They had not submitted what was required.

* Dr. Lillian Yin, FDA --again, a long letter responding to a forwarded letter I'd sent to Surgeon General Dr. Jocelyn Elders on 9/14/93. (And she copied everyone short of God :-)))

Dr. Yin repeated the information in her earlier letters to me, adding that the FDA, in collaboration with the CDC and the NIH, had developed an expedited protocol for the development of female barrier contraceptives. This was approved and issued in April of 1990. She went on to describe Wisconsin Pharmacal's "Reality" condom as being "similar" to the Bikini Condom (not!) and said this was the first of its type to be reviewed using that new protocol (approved for marketing on 5/7/93).

She went on to emphasize how important it was for manufacturers (like Reddy Health) to adhere to the process for ensuring safe and effective medical devices and invited my to call her with any further questions.

* Reddy Health Care, Inc./International Prophylactics, Inc. --makers of the Bikini Condom, who responded with 3 letters to me in 1993.

Note: I never told them that I'd designed a panty condom in 1980. I wanted Reddy Health to be able to continue soliciting investment in good faith --on the basis of the originality of their (alleged) patent. (I suspected that they might have gotten the idea directly or through some intermediary as a consequence of my barrages of letters in 1981, 1985 or 1987.)

* They had at one point gained approval to distribute the Bikini Condom in Canada, per a letter from Mr. Keith F. Heintz (VP of Operations) on  2/24/93 to the executive director at the Siuslaw Area Women's Center (Florence, Oregon), but then their United States FDA approval was rescinded. Mr. Heintz cited "politics" as the reason, asking the Women Center's director to examine their literature and consider writing a letter to the FDA urging that their previous approval be reinstated.

~~~~~~~~~~~~~~~~~~~~~~~

Reddy Health's 7/9/93 to me:

"Dear Craig:

I received your letters and first want to thank you for taking some interest in our situation. I also hope you know some of the frustration we here at Reddy have been feeling. One point though that I feel may have been missed is that the FDA did give the Bikini Condom approval through the 510(k) process. To prove that point, please see the approval letter (attached) from the FDA indicating that the device has been found to be substantially equivalent to a pre-amendment device.

Some time after that letter was written the FDA had a "change of heart" and decided that they should not have given their approval to the device, so they took their approval back --while indicating that with the additional work and studies, we could resubmit to gain, once again, the approval we once had.

Needless to say, all that we have been through has cost a considerable amount of money and the dilemma we find ourselves in is being out of money and unable to even put enough money together to take the Bikini Condom to market in parts of the world where we have approval to do so.

I feel you have begun to understand the essence of the problem and that is, simple things may be complex, but it takes people to make simple things so complicated that common sense no longer tends to prevail. You are right, this product has tremendous potential to save lives and virtually no possibility of killing a user.

Thank you once again for your interest and I appreciate your keeping me updated on any responses you get to your letters. We here at Reddy are not giving up on the Bikini Condom, but we are actively trying to obtain additional funds to complete the additional work.
 

Sincerely,

Keith F. Heintz / Vice President of Operations"

~~~~~~~~~~~~~~~~~~~~~

* Dr. Patrick Friel, a scientist with the World Health Organization wrote to me on 1/27/93. It was this helpful letter which alerted me to the "Bikini Condom". They had prototypes and, had it been in actual production then, the WHO might have gone with it instead of Wisconsin Pharmacal's double-funnel "Reality" brand device.

* Ms. Cindy Pearson, Program Director, National Women's Health Network, in a hand written letter of 6/26/93, agreed it was frustrating not to have a device that women can use for protection, but she also agreed with the FDA's prevention of the Bikini Condom from being sold in the U.S. --on account of Reddy Health Care's "unwillingness" to do more tests. (At one point I wrote to radio broadcast doctor Dean Edel, who apparently contacted Reddy Health Care to learn that they needed more investment, which he mentioned on his show).

* Consumers Union, wrote back to me on 12/20/93 --saying "they'd look into it".

8 months passed, so I wrote again to Mr. Albert Lopez of Consumers Union on 8/11/94, per:

~~~~~~~~~~~~~~

Dear Mr. Lopez,

Has CU determined yet why the "Bikini Condom" never reached the market? It's been languishing since its patent in 1987 --while a million people have become infected with AIDS.

CU could perform a signal service to the world by determining just WHO is sitting on this and motivating the right parties to perform.

I suspect that there's a terrible scandal of stupidity on the part of International Prophylactics and/or the FDA. Were this a military invention capable of defending the nation against attack, it would have been swept right out of idle hands and had a billion dollars squandered on it --for better or for worse.

Well: this IS a device capable of defending the nation against attack! What's wrong?
 

Sincerely,

Craig Daniels

[There was no further response.]

~~~~~~~~~~~~~~~~~

* Planned Parenthood USA finally responded on 9/7/99, promising to "look into it".

* Reproduction Research Institute wrote to me in December of 1999 and invited me to write to them again, but there were no subsequent responses.

* Ms. Cindy Pearson, Executive Director, National Women's Health Network. In a very nice hand written letter of 8/21/2001, she thanked me for my long effort. She's squarely behind the Janesway project :-)

(Should you be looking for an interesting investment, Ms. Pearson can put you in touch with the right people.)
 

~~~~~~~~~~~~~~~~~~~~~Older web site copy --poorly revised:

* Until 11/27/00, the best information I had (which included good medical authority) was that I'd coined the term "Female Condom" and first seriously suggested a garment prophylactic in 1980. It turned out, however, that there was at least a device in the 1930s which was somewhat similar to what's now being marketed under the "Reality" and "Femidon" brand names --and it was most certainly called a "female condom" (at least informally).

My garment design included a large molded-in male style condom, appropriately located. The whole garment was to be sheer but impervious, thus covering and protecting the vagina, meatal, and perennial areas. Its leg openings were to be gently ligatured for added protection. I suggested its suitability for male homosexual penetration as well.

I sent off a barrage of letters in 1980/81 to prophylactics manufacturers and Planned Parenthood, again a few years later, and to various government offices. I renewed my efforts periodically thereafter until belatedly learning (from the United Nations WHO offices) about the 1987 Bikini patent by one "Dr. Reddy".

At that point (1990s) I shut up --so as not to challenge the originality of Reddy's claims.

Or: the Bikini Condom was said to have been patented. My search for the patent turned up nothing, but something did happen in 1987, per the FDA item below.

Perhaps the '87 patent existed but was voided for lack of renewal, pursuant to relatively recent requirements of a patent needing to be serviced by claimants at the 5th and 10th years. (I'm but vaguely aware of patent searches and law, so be sure to check my information.) (I've been given an opinion [not for attribution] that the Reddy patent was thus "abandoned".)

Another patent was issued in 1997: #5,596,997 to one Max M. Abadi (and see his earlier citations if you look it up).

Sadly, I only stumbled upon the Abadi device when I noticed an article ridiculing him and the basic garment device concept --posted somewhere on the Internet.

*** Until 2001, I only knew of one woman who liked the idea of the Bikini Condom. It seems odd that even well intentioned, otherwise progressive minds will disregard novelty out-of-hand, reflexively rejecting changes from tradition, new information (and those who bear it) with little regard for questions of utility, need, or even self interest. I suppose it has something to do with how we're seemingly "programmed" to give highest priority to conserving patterns --any pattern, or even just the perception of patterns and assumed social order.

Perhaps this is the culture's unconscious automatic test of the creative elements in our society, --which is somehow, blindly, stupidly, "best" for us in the long run.

Previous to the Janesway effort, this had been the best commercial effort: a vulva enveloping garment, appropriately named: the "Bikini Condom".
 

* on the partner who doesn't grossly (so to speak) change size,

* on the partner who's most at risk as to consequences,

* on the partner who can don it well in advance of an encounter --and can take it off well afterwards.

--AND in the in-between: "there's no stopping" ;-)  --and there's no need to withdraw before the guy "shrinks" in order to wait out an indeterminate refractory period.

Prediction: After fashionable opinion leaders and celebrities have given the rest of us permission to think about the female condom; once it becomes popularly understood --that using the Janesway female condom is very much like making care-free love without a condom at all:

That term will replace "your father's Oldsmobile" as metaphor for what deserves to be obsolete --and for those who mindlessly resist social progress.

I've been out of contact with Dr. Reddy and his VP for Operations Keith F. Heintz for 9 years now.

* All this while, women's clinics and counseling groups have been distributing male condoms to their female clients. You'd think the feminist lobby would have torn up Washington DC to get the government and the FDA off their duffs but, previous to August of 2001, the only mention I've heard of their involvement was to oppose(!) --on the basis that it "lessens male responsibility". ("Empowerment" --anyone?)

~~~~~~~~~~~~~~~~~~

See: http://www.zpg.org/Press_Releases/press37.html

--which might be the "Bikini" --if an item I heard on a radio broadcast was correct.

See also: http://www.fda.gov/ohrms/dockets/98fr/061099a.txt

---from which we read:

"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)."

[That's has to be Dr. Reddy's outfit, but a search on "Energy Basin Clinic" turns up nothing. --Craig]

~~~~~~~~~~~~~~~~~~

The rest of this is more about the "Reality" brand item and the interesting "Gee Bee Ring" (optional reading):

"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).

[Who's that?? Mr. Abadi got his patent in 1997. --Craig]

    On May 29, 1993, FDA approved the PMA for the Wisconsin Pharmacal
Co. ``Reality'' Female Condom (Ref. 8).

[That took 4 years. --Craig]

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."