Document ID: FDA-2017-N-6538-0001
Agency: fda
Document Type: Proposed Rule
Title: Obstetrical and Gynecological Devices; Reclassification of Single-Use
Female Condom, To Be Renamed Single-Use Internal Condom
Posted Date: 2017-12-04T05:00Z

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Proposed Rules]
[Pages 57174-57180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-6538]

Obstetrical and Gynecological Devices; Reclassification of 
Single-Use Female Condom, To Be Renamed Single-Use Internal Condom

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify single-use female condoms, renaming the device to ``single-
use internal condom,'' a postamendments class III device (product code 
MBU), into class II (special controls) subject to premarket 
notification (510(k)). FDA is also identifying the proposed special 
controls that the Agency believes are

[[Page 57175]]

necessary to provide a reasonable assurance of safety and effectiveness 
of the device. FDA is proposing this reclassification on its own 
initiative based on new information. FDA is also proposing to amend the 
existing device identification for ``female condom,'' a preamendments 
class III device (product code OBY), by renaming the device ``multiple-
use female condom,'' to distinguish it from the ``single-use internal 
condom.'' If finalized, this order will reclassify single-use female 
condoms from class III to class II and reduce regulatory burdens on 
industry as these types of devices will no longer be required to submit 
a premarket approval application (PMA) but can instead submit a less 
burdensome 510(k) before marketing their device.

DATES: Submit either electronic or written comments on the proposed 
order by February 2, 2018. Please see section IX of this document for 
the proposed effective date of any final order that may publish based 
on this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 2, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal Rulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for paper submissions): 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to Dockets Management 
Staff, FDA will post your comment, as well as any attachments, except 
for information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6538 for ``Obstetrical and Gynecological Devices; 
Reclassification of Single-Use Female Condom, To Be Renamed Single-Use 
Internal Condom.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Monica Garcia, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G215, Silver Spring, MD 20993, 240-402-2791, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
amended, establishes a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the FD&C Act (21 
U.S.C. 360c) established three categories (classes) of devices, 
reflecting 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(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as ``preamendments devices''), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee) (the Panel); (2) 
published the Panel's recommendation 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 
automatically classified by section 513(f)(1) of the FD&C Act into 
class III without any FDA rulemaking process. Those devices remain in 
class III and require premarket approval unless, and until, the device 
is reclassified into class I or II, or FDA issues an order finding

[[Page 57176]]

the device to be substantially equivalent, in accordance with section 
513(i) of the FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807).
    A postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified into 
class I or class II under section 513(f)(3) of the FD&C Act. On July 9, 
2012, Food and Drug Administration Safety and Innovation Act (FDASIA) 
(Pub. L. 112-144) was enacted. Section 608(a) of FDASIA amended section 
513(e) of the FD&C Act, changing the process for reclassifying a device 
from rulemaking to an administrative order. Section 513(e) provides 
that FDA may, by administrative order, reclassify a device based upon 
``new information.'' The term ``new information,'' as used in section 
513(e) of the FD&C Act, includes information developed as a result of a 
reevaluation of the data before the Agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at the time. To change the classification 
of the device, the proposed new class must have sufficient regulatory 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use.
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available regulatory authority (see Bell v. Goddard, 
366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 
382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical 
science'' (Upjohn Co. v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). 
Whether data before the Agency are old or new, the ``new information'' 
to support reclassification under section 513(f)(3) must be ``valid 
scientific evidence'', as defined in section 513(a)(3) of the FD&C Act 
and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 
F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 
592 (D.C. Cir.1985), cert. denied, 474 U.S. 1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 
520(h)(4) of the FD&C Act provides that FDA may use, for 
reclassification of a device, certain information in a PMA 6 years 
after the application has been approved. This includes information from 
clinical and preclinical tests or studies that demonstrate the safety 
or effectiveness of the device, but does not include descriptions of 
methods of manufacture or product composition and other trade secrets.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements, if the Agency 
determines that premarket notification is not necessary to reasonably 
assure the safety and effectiveness of the device.

II. Device Description and Regulatory History

    A single-use female condom is a sheath-like device that is inserted 
into the vagina prior to the initiation of coitus and discarded at its 
conclusion. It includes a mechanism (e.g., flexible rings) to hold the 
device in place during sexual intercourse. The device is a mechanical 
barrier that is intended to protect the user from sexually transmitted 
infections (STIs) and prevent pregnancy. The female condom is distinct 
from the male condom, which is a sheath that completely covers the 
penis, because it is inserted internally prior to intercourse. Based on 
the differences in technology, these devices have different failure 
modes and therefore have distinct classifications. Male condoms that 
completely cover the penis with a closely fitting membrane are 
regulated as class II devices under Sec. Sec.  884.5300 and 884.5310 
(21 CFR 884.5300 and 884.5310). A single-use female condom (product 
code MBU) is a postamendments device currently regulated as a class III 
device under section 513(f)(1) of the FD&C Act. FDA first learned of 
the device in January 1989, when FDA received a 510(k) from the 
Wisconsin Pharmacal Company, LLC (WPC). The device was intended to line 
the vaginal wall during sexual intercourse for purposes of 
contraception and STI prophylaxis. At that time, the device was named 
the WPC-333 device but later renamed the Femshield/Reality Female 
Condom. WPC purported in its 510(k) that the Reality Female Condom was 
substantially equivalent to the male condom identified in Sec.  
884.5300, as well as to a preamendments female condom known as the Gee 
Bee Ring. WPC provided documentation in the 510(k) that indicated the 
Gee Bee Ring was a pouch-like device designed to line the wall of the 
vagina during coitus for contraceptive (pregnancy prevention) and 
prophylactic (prevention of STI transmission) purposes. However, in 
contrast to the Reality Female Condom, the Gee Bee Ring was indicated 
for reuse (versus single-use) and was made using animal tissue (versus 
polyurethane).
    Before receiving WPC's 510(k), FDA was unaware of the existence, 
commercial distribution, and use of the Gee Bee Ring as a female 
condom. FDA verified the preamendments status and uses of the Gee Bee 
Ring, and presented this information to the Obstetrics and Gynecology 
Devices Panel (referred to as the Classification Panel) on March 7, 
1989. The Classification Panel reviewed all available information 
concerning the classification of a sheath-like device that is inserted 
into the vagina prior to coitus for purposes of contraception and STI 
prophylaxis. The Classification Panel recommended that FDA classify 
this generic type of device as distinct from the male condom identified 
in Sec.  884.5300. The Classification Panel also recommended that this 
device be classified into class III, because no published laboratory or 
clinical study data could be found that would allow FDA to establish 
special controls for the device, and the device is purported or 
represented to be for a use which is of substantial importance in 
preventing impairment of human health. FDA agreed with the 
Classification Panel's recommended classification, and in the Federal 
Register of June 10, 1999 (64 FR 31164), FDA published a proposed rule 
to create a new classification regulation (Sec.  884.5330 (21 CFR 
884.5330)) for the female condom and classify the device in class III. 
FDA finalized this rule on May 18, 2000 (65 FR 31454). The Gee Bee Ring 
is the only female condom regulated under Sec.  884.5330 and is 
identified using FDA product code OBY. In the Federal Register of 
August 25, 2010 (75 FR 52294), FDA published a proposed rule to require 
the filing, under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)), 
of a PMA or notice of completion of a product development protocol for 
any female condom that was in commercial distribution before May 28, 
1976. FDA finalized this rule on August 16, 2011 (76 FR 50663) and 
noted that the Agency has no record of the Gee Bee Ring being marketed 
after it was classified in 2000.
    In April 1989, FDA completed its review of WPC's 510(k) and 
determined that the Reality Female Condom was not

[[Page 57177]]

substantially equivalent to either the male condom identified in Sec.  
884.5300 or the Gee Bee Ring. As a result, in accordance with section 
513(f)(1) of the FD&C Act, the Reality Female Condom was automatically 
classified into class III. On May 7, 1993, FDA approved the PMA for the 
Reality Female Condom (P910064) and subsequently FDA identified this 
device type with the product code MBU (Ref. 1). On April 14, 1995, FDA 
approved the PMA for the Femidom Female Condom (P940033), which is 
identical to the Reality Female Condom. In this PMA, WPC authorized 
Chartex International plc to incorporate information contained in its 
approved PMA for the Reality Female Condom (Ref. 2). On January 8, 
2008, FDA received a PMA (P080002) from the Female Health Company for 
the FC2 Female Condom and approved it on March 10, 2009 (Ref. 3). The 
FC2 Female Condom is a modified version of the Reality Female Condom. 
Since the introduction of the FC2 Female Condom, the Reality Female 
Condom has been referred to as the FC1 Female Condom. The FC2 Female 
Condom is a specific example of a single-use female condom that is the 
subject of this reclassification and is currently the only FDA-approved 
single-use female condom that is being marketed in the United States.
    As part of the Center for Devices and Radiological Health's 2014-
2015 strategic priority ``Strike the Right Balance Between Premarket 
and Postmarket Data Collection,'' a retrospective review of class III 
devices subject to PMA was completed to determine whether or not, based 
on our current understanding of the technology, reclassification may be 
appropriate. On April 29, 2015, FDA published a notice in the Federal 
Register entitled ``Retrospective Review of Premarket Approval 
Application Devices; Striking the Balance Between Premarket and 
Postmarket Data Collection'' in which FDA announced plans to consider 
reclassifying single-use female condoms identified with the MBU product 
code from class III to class II (80 FR 23798). Following this notice, 
FDA received seven comments, six of which supported reclassification of 
MBU. One comment did not support reclassification because it was stated 
that FDA lacked information to determine what risks might exist for 
female condoms of different design, materials, and manufacturing 
processes. FDA considered all comments in proceeding with this proposed 
order to reclassify single-use female condoms from class III to class 
II.

III. Proposed Reclassification and Summary of Reasons for 
Reclassification

    FDA is proposing to reclassify single-use female condoms from class 
III into class II because sufficient information exists to establish 
special controls. FDA believes that these special controls, together 
with general controls, will provide a reasonable assurance of the 
device's safety and effectiveness for single-use female condoms.
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR 
part 860, subpart C, FDA is proposing to reclassify this postamendments 
class III device into class II (special controls). FDA believes that 
there is sufficient information from nonclinical and clinical data 
submitted in PMA applications P910064 (Ref. 1), P940033 (Ref. 2), and 
P080002 (Ref. 3), available to FDA under section 520(h)(4) of the FD&C 
Act; postmarket experience; and peer-reviewed literature (Refs. 4-7) to 
establish special controls that can effectively mitigate the risks to 
health of single-use female condoms that are identified in section IV. 
Absent the special controls identified in this proposed order, general 
controls applicable to the device are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device.
    FDA is also proposing to amend the existing device identification 
for female condom (Sec.  884.5330), a preamendments class III device, 
by renaming the device ``multiple-use female condom'' to better 
distinguish it from the ``single-use female condom'' that is the 
subject of this reclassification. One difference between the 
preamendments female condom (product code OBY) and the postamendments 
female condom (product code MBU) is that the preamendments female 
condom is indicated to be cleaned at the conclusion of coitus and 
reused. Additionally, a minor revision to the identification language 
is being proposed to change the term ``diseases'' to ``infections'' to 
use more appropriate clinical terminology. This proposed revision does 
not substantively change the meaning. It will remain a class III 
device, as FDA has neither received nor identified valid scientific 
evidence from nonclinical or clinical studies that demonstrate the 
safety and effectiveness of that type of female condom. Additionally, 
FDA is unaware of valid scientific evidence regarding the reuse of 
condoms (female or male) that could be used to establish special 
control(s) for a multiple-use female condom to provide a reasonable 
assurance of safety and effectiveness.
    FDA is proposing to identify the single-use female condom that is 
the subject of this proposed order under the new name ``single-use 
internal condom'' to indicate that the new classification regulation 
includes the use of these devices inserted internally for vaginal and/
or anal intercourse. This technology is distinct from that of male 
condoms, which completely cover the penis with a closely fitting 
membrane. This proposed classification does not include male condoms 
that are class II devices regulated under Sec. Sec.  884.5300 and 
884.5310. FDA believes use of this device for vaginal and anal 
intercourse engender the same risks to health (with the exception of 
the risk of pregnancy when used for anal intercourse) and that the 
proposed special controls can effectively mitigate those risks when the 
device is used for these purposes.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, FDA does not intend to exempt the proposed class II devices 
from 510(k) requirements. Persons who intend to market this type of 
device must submit to FDA a 510(k) and receive clearance prior to 
marketing the device.

IV. Risks to Health

    After considering the information available to FDA from the 
recommendations of the Classification Panel for the classification of 
these devices (Refs. 8 and 9); data in PMA applications P910064, 
P940033, and P080002 available to FDA under section 520(h)(4) of the 
FD&C Act; postmarket experience; and peer-reviewed literature (Refs. 4-
7), FDA determined that the probable risks to health associated with 
the use of single-use internal condoms are as follows:
     Pregnancy--Slippage, breakage, misdirection, or 
invagination of the device during vaginal intercourse could result in 
the occurrence of an undesired pregnancy.
     Transmission of infection--If the device fails due to 
slippage, breakage, misdirection, or invagination, contact with 
infected semen or vaginal secretions or vaginal/anal mucosa could 
result in the transmission of sexually-transmitted infections.

[[Page 57178]]

     Adverse tissue reaction--If the patient-contacting 
materials of the device are not biocompatible, local tissue irritation 
and sensitization, cytotoxicity, or system toxicity could occur when 
the device contacts the vagina, cervix, anus, and external male and 
female genitalia.
     Ulceration and other physical trauma--Use of the internal 
condom may cause abrasions, lacerations, bleeding, or other adverse 
effects to the vaginal, anal, or penile tissue if the device is not 
designed appropriately.

V. Summary of Data Upon Which the Reclassification Is Based

    FDA has considered and analyzed the following information: The 
Manufacturer and User Facility Device Experience (MAUDE) database; data 
contained in PMAs approved 6 or more years before the date of this 
proposed order (reviewed under section 520(h)(4) of the FD&C Act, also 
known as the 6-year rule) (Ref. 10); the published literature; and the 
recommendations of the Classification Panel and FC1 and FC2 Panels.
    Since 1993, the Center for Devices and Radiological Health (CDRH) 
has received one medical device report (MDR) regarding an adverse event 
associated with the use of an internal condom. This MDR reported injury 
following off-label use of the FC1 Female Condom during anal 
intercourse; the FC1 Female Condom is indicated for vaginal 
intercourse. Considering the number of internal condoms distributed in 
the United States since 1993 (approximately 3 to 4 million per year), 
the number of adverse events reported is low. FDA acknowledges that 
because internal condoms are over-the-counter devices, adverse events 
may be under reported.
    Starting in 1989, several Panel meetings were held to discuss the 
safety and effectiveness of the internal condom. During the March 7, 
1989, meeting, the Classification Panel recommended that the internal 
condom be classified into class III due to the absence of testing and 
clinical medical data regarding the safety and effectiveness of the 
device. On January 31 and December 10, 1992, the Obstetrics and 
Gynecology Devices Panel (referred to as the ``FC1 Panel'') was 
convened to discuss the safety and effectiveness of the FC1 Female 
Condom and provide recommendations to FDA regarding a specific PMA 
application (P910064). During these meetings, the FC1 Panel discussed 
the available nonclinical and clinical data on the FC1 Female Condom, 
which included an acute failure modes study and contraceptive 
effectiveness study. On December 10, 1992, the FC1 Panel expressed 
concern regarding the high failure rates (21.7 percent rate of 
pregnancy in the Latin American population, 21.4 percent rate of 
pregnancy in U.S. women less than 25 years of age, 5.4 percent total 
clinical failure rate) of the FC1 Female Condom but recommended 
approval with conditions, which included labeling changes aimed at 
limiting the safety and effectiveness claims and the development of 
physician labeling. The FC1 Panel based this decision on the fact that 
no other barrier method existed for women to protect themselves against 
transmission of STIs if their partner would not use a male condom.
    On January 8, 2008, FDA received a PMA (P080002) from the Female 
Health Company for the FC2 Female Condom (an updated version of the 
Reality Female Condom, now also referred to as the FC1 Female Condom), 
comprised of a nitrile sheath, nitrile outer ring, and polyurethane 
inner ring. Data provided in this PMA demonstrated that the FC2 Female 
Condom is an effective barrier to viral particles, is biocompatible, 
has acceptable mechanical properties, and has comparable rates of total 
clinical failure (2.18 percent) when compared to the FC1 Female Condom 
(2.92 percent). On December 11, 2008, CDRH convened the Obstetrics and 
Gynecology Devices Panel (referred to as the ``FC2 Panel'') in 2008 to 
discuss the safety and effectiveness of the FC2 Female Condom. The FC2 
Panel recommended approval of the device with conditions, which 
included labeling changes aimed at improving consumer understanding of 
possible failure modes of the FC2 Female Condom and the outcomes of the 
acute failure modes study. The FC2 Panel found that the acute failure 
modes study comparing the FC2 Female Condom to the FC1 Female Condom 
provided a reasonable assurance of the safety and effectiveness for the 
FC2 Female Condom. Additionally, the FC2 Panel did not believe a 
contraceptive effectiveness study was needed to demonstrate reasonable 
assurance of safety and effectiveness because of the similarities in 
design between the FC2 and FC1 Female Condoms and the results of the 
acute failure modes study, which demonstrated comparable rates of 
clinical failure between the two female condoms. However, the FC2 Panel 
noted that the recommendation to not require a contraceptive 
effectiveness study applied only to the FC2 Female Condom and not other 
female condoms. As outlined in the proposed special controls in section 
VI, FDA has determined that a contraceptive effectiveness study is 
necessary to mitigate the risks to health related to pregnancy for this 
device type when used for vaginal intercourse.
    A review of published literature evaluating the clinical use of the 
FC2 Female Condom indicates that clinical failure occurred in less than 
5 percent of device uses (Refs. 4-7). Clinical failure is defined as 
the sum total of acute failure events for the internal condom. For the 
FC2 Female Condom, the acute failure events are slippage, breakage, 
misdirection, and invagination. This clinical failure rate may decrease 
with increased user experience with internal condoms (Ref. 5). The 
adverse events experienced by users of internal condom were infrequent 
and mild. The results of these published studies indicate that the FC2 
Female Condom is effective and has a favorable safety profile. FDA 
identified no new risks or safety and effectiveness concerns from the 
published literature that it did not previously identify through its 
review of the PMAs or either of the prior Obstetrics and Gynecology 
Devices Panel (``The Panel'') discussions of the female condom.
    FDA acknowledges that the available valid scientific evidence, 
including the review of the MAUDE database, previous PMA approvals and 
The Panel discussions, and the published literature, primarily discuss 
use of internal condoms for vaginal intercourse. FDA believes that with 
the exception of pregnancy, the risks associated with internal condoms 
for vaginal intercourse are the same as those for anal intercourse 
(Refs. 11-13). Accordingly, FDA has tentatively determined that special 
controls can be established, in combination with general controls, 
which will provide reasonable assurance of the safety and effectiveness 
of internal condoms used for anal intercourse.
    Based on its review of the FC1 and FC2 Female Condom PMAs; the 
discussions of the Classification Panel, FC1 Panel, and FC2 Panel on 
the safety and effectiveness of the internal condom; and peer-reviewed 
published literature, FDA has tentatively determined that available 
nonclinical and clinical performance data support that the risks 
associated with the internal condom are well understood and can be 
mitigated through special controls, including performance testing and 
labeling. FDA has also tentatively determined that the identified 
mitigation measures can be used to establish special controls, in 
addition to general controls, which are necessary to

[[Page 57179]]

provide a reasonable assurance of safety and effectiveness for this 
device type. FDA believes that premarket notification and establishment 
of special controls will allow for assessment of the design and 
materials of single-use internal condoms through completion of a risk 
analysis, biocompatibility testing, mechanical performance testing, 
viral penetration testing, and clinical performance testing and 
sufficient labeling. FDA, on its own initiative, is proposing to 
reclassify this postamendments class III device type into class II.

VI. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls, address the risks to health and provide reasonable 
assurance of safety and effectiveness to mitigate the risks to health 
described in section V for the aforementioned single-use internal 
condoms.
    The risks of pregnancy and STI are the most clinically significant 
risks of the single-use internal condom when used for vaginal and/or 
anal intercourse. Clinical testing is necessary to mitigate these risks 
to health. Clinical testing evaluates the rate of total clinical 
failure of the device and the rate of individual failure modes 
(slippage, breakage, misdirection, invagination, and other failure 
modes as appropriate) when the device is used as intended (i.e., during 
vaginal and/or anal intercourse). When the device is indicated for 
vaginal intercourse, clinical testing evaluates the cumulative 
pregnancy rate based on a contraceptive effectiveness study.
    To mitigate the risk of STI due to contact with infected semen or 
vaginal secretions or vaginal/anal mucosa, FDA believes that a viral 
penetration study is needed to demonstrate that the device is an 
effective barrier to STIs.
    In addition to clinical testing and viral penetration testing to 
mitigate the risks of pregnancy and STI, FDA believes that the device 
must demonstrate that it performs as intended under the anticipated 
conditions of use (i.e., vaginal and/or anal intercourse). Mechanical 
testing of the device must demonstrate that the device can withstand 
forces under anticipated use conditions by evaluation of the tensile, 
tear, and burst properties of the device. Compatibility testing with 
personal lubricants must determine whether the physical properties of 
the device are adversely affected by use of additional lubricants. 
Furthermore, shelf-life testing must demonstrate that the device 
maintains its performance characteristics and the packaging of the 
device maintains its integrity for the duration of the proposed shelf-
life. The risk of an adverse tissue reaction due to the patient-
contacting materials of the device is an additional risk of the single-
use internal condom when used for vaginal and/or anal intercourse. In 
order to mitigate this risk, FDA believes the device must demonstrate 
biocompatibility.
    FDA also believes that comprehensive labeling describing risks and 
mitigation measures associated with the single-use internal condom must 
be listed. When the device is indicated for vaginal intercourse, the 
labeling must include a contraceptive effectiveness table comparing 
typical use (actual use of the method, including inconsistent and 
incorrect use) and perfect use (when used correctly 100 percent of the 
time) pregnancy rates of the device to other available methods of birth 
control. The labeling must also list the adverse events associated with 
the device, including potential transmission of infection, adverse 
tissue reaction, and ulceration or other physical trauma. Because the 
physical properties of the device may be adversely affected by the use 
of personal lubricants, the labeling must specify whether the device is 
compatible with additional types of personal lubricants (e.g., water-
based, silicone-based). Finally, the labeling must specify an 
expiration date to ensure that the device performs as intended over the 
stated shelf-life.
    Table 1 shows how FDA believes that the risks to health identified 
in section IV can be mitigated by the proposed special controls. This 
reclassification order and the identified special controls, if 
finalized, would provide sufficient detail regarding FDA's requirements 
to reasonably assure safety and effectiveness of single-use internal 
condoms.

                Table 1--Risks to Health and Mitigation Measures for Single-Use Internal Condoms
----------------------------------------------------------------------------------------------------------------
           Identified risks to health                                   Mitigation measures
----------------------------------------------------------------------------------------------------------------
Pregnancy.......................................  Contraceptive effectiveness study.
                                                  Acute failure modes study.
                                                  Nonclinical performance testing.
                                                  Shelf-life.
                                                  Labeling.
Transmission of Infection.......................  Acute failure modes study.
                                                  Viral penetration study.
                                                  Nonclinical performance testing.
                                                  Shelf-life.
                                                  Labeling.
Adverse tissue reaction.........................  Biocompatibility.
                                                  Labeling.
Ulceration and other physical trauma............  Acute failure modes study.
                                                  Nonclinical performance testing.
                                                  Shelf-life.
                                                  Labeling.
----------------------------------------------------------------------------------------------------------------

VII. Analysis of 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.

VIII. Paperwork Reduction Act of 1995

    This proposed order refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 807, subpart E, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 814,

[[Page 57180]]

subparts A through E, have been approved under OMB control number 0910-
0231; and the collections of information under 21 CFR part 801 have 
been approved under OMB control number 0910-0485.

IX. Proposed Effective Date

    FDA proposes that any final order based on this proposed order 
become effective 30 days after the date of its publication in the 
Federal Register.

X. References

    The following references are on display in Dockets Management Staff 
(see ADDRESSES), and are available for viewing by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday; most are available 
electronically at https://www.regulations.gov. FDA has verified the Web 
site addresses, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.

    1. P910064 Summary of Safety and Effectiveness Data (SSED).
    2. P940033 Premarket Approval Notice (60 FR 30310, June 8, 
1995).
    3. P080002 SSED is available on FDA's Web site at https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080002B.pdf.
    4. Joanis, C., M. Beksinska, C. Hart, et al., ``Three New Female 
Condoms: Which Do South-African Women Prefer?'' Contraception, 
83(3):248-254, 2011.
    5. Beksinska, M., J. Smit, C. Joanis, et al., ``Practice Makes 
Perfect: Reduction in Female Condom Failures and User Problems With 
Short-Term Experience in a Randomized Trial.'' Contraception, 
86(2):127-131, 2012.
    6. Beksinska, M.E., G. Piaggio, J.A. Smit, et al., ``Performance 
and Safety of the Second-Generation Female Condom (FC2) Versus the 
Woman's, the VA Worn-of-Women, and the Cupid Female Condoms: A 
Randomised Controlled Non-Inferiority Crossover Trial.'' The Lancet 
Global Health, 1(3):e146-152, 2013.
    7. Beksinska, M., R. Greener, I. Kleinschmidt, et al., ``A 
Randomized Noninferiority Crossover Controlled Trial of the 
Functional Performance and Safety of New Female Condoms: An 
Evaluation of the Velvet, Cupid2, and FC2.'' Contraception, 
92(3):261-267, 2015.
    8. The panel transcript and other meeting materials for the 
December 11, 2008, Obstetrics and Gynecology Devices Panel are 
available on FDA's Web site at https://wayback.archive-it.org/7993/20170405192707/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm433049.htm.
    9. The panel transcript and other meeting materials for the 
March 7, 1989, January 31, 1992, and December 10, 1992, Obstetrics 
and Gynecology Devices Panel.
    10. ``Guidance for Industry and for FDA Reviewers: Guidance on 
Section 216 of the Food and Drug Administration Modernization Act of 
1997,'' issued on August 9, 2000. Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073709.pdf.
    11. Kelvin, E.A., J.E. Mantell, N. Candelario, et al., ``Off-
Label Use of the Female Condom for Anal Intercourse Among Men in New 
York City.'' American Journal of Public Health, 101(12):2241-2244, 
2011.
    12. Gross, M., S.P. Buchbinder, S. Holte, et al., ``Use of 
Reality `Female Condoms' for Anal Sex by US Men Who Have Sex With 
Men. HIVNET Vaccine Preparedness Study Protocol Team.'' American 
Journal of Public Health, 89(11):1739-1741, 1999.
    13. Renzi, C., S.R. Tabet, J.A. Stucky, et al., ``Safety and 
Acceptability of the Reality Condom for Anal Sex Among Men Who Have 
Sex With Men.'' AIDS, 17(5):727-731, 2003.

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

0
1. The authority citation for part 884 continues to read as follows:

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

0
2. Amend Sec.  884.5330 in Subpart F by revising the section heading 
and paragraph (a) to read as follows:

Sec.  884.5330   Multiple-use female condom.

    (a) Identification. A multiple-use female condom is a sheath-like 
device that lines the vaginal wall and is inserted into the vagina 
prior to the initiation of coitus. At the conclusion of coitus, the 
device can be reused. It is indicated for contraception and 
prophylactic (preventing the transmission of sexually transmitted 
infections) purposes.
* * * * *
0
3. Add Sec.  884.5340 in Subpart F to read as follows:

Sec.  884.5340   Single-use internal condom.

    (a) Identification. A single-use internal condom is a sheath-like 
device that lines the vaginal or anal wall and is inserted into the 
vagina or anus prior to the initiation of coitus. At the conclusion of 
coitus, it is removed and discarded. It is indicated for contraception 
and/or prophylactic (prevention of sexually transmitted infections) 
purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) Rate of clinical failure of the device and rate of individual 
failure modes of the device based on an acute failure modes study 
evaluating the intended use (vaginal and/or anal intercourse); and
    (ii) Cumulative pregnancy rate when using the device based on a 
contraceptive effectiveness study (when the device is indicated for 
vaginal intercourse).
    (2) Viral penetration testing must demonstrate the device is an 
effective barrier to sexually transmitted infections.
    (3) Nonclinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Mechanical testing must demonstrate the device can withstand 
forces under anticipated use conditions, include evaluation of tensile, 
tear, and burst properties of the device.
    (ii) Compatibility testing with personal lubricants must determine 
whether the physical properties of the device are adversely affected by 
use of additional lubricants.
    (4) The device must be demonstrated to be biocompatible.
    (5) Shelf-life testing must demonstrate that the device maintains 
its performance characteristics and the packaging of the device must 
maintain integrity for the duration of the shelf-life.
    (6) Labeling of the device must include:
    (i) Contraceptive effectiveness table comparing typical use and 
perfect use pregnancy rates with the device to other available methods 
of birth control;
    (ii) Statement regarding the adverse events associated with the 
device, including potential transmission of infection, adverse tissue 
reaction, and ulceration or other physical trauma;
    (iii) Expiration date; and
    (iv) Statement regarding compatibility with additional types of 
personal lubricants.

    Dated: November 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26011 Filed 12-1-17; 8:45 am]
 BILLING CODE 4164-01-P