[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Rules and Regulations]
[Pages 48711-48714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21044]


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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: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
issuing a final order to reclassify single-use female condoms, renaming 
the device to ``single-use internal condom,'' a postamendments class 
III device (regulated under product code MBU), into class II (special 
controls) subject to premarket notification (510(k)). FDA is also 
identifying the special controls that the Agency believes are necessary 
to provide a reasonable assurance of safety and effectiveness of the 
device. FDA is finalizing this reclassification on its own initiative 
based on new information. FDA is also amending 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.'' 
This order reclassifies single-use internal condoms from class III to 
class II and reduces regulatory burden because 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: This order is effective October 29, 2018.

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

    The Federal Food, Drug, and Cosmetic Act (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).
    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 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 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. Section 
513(f)(3) of the FD&C Act provides that FDA acting by order can 
reclassify the device into class I or class II on its own initiative, 
or in response to a petition from the manufacturer or importer of the 
device. 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

[[Page 48712]]

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 510(k) premarket notification requirements, if the 
Agency determines that premarket notification is not necessary to 
reasonably assure the safety and effectiveness of the device.
    On December 4, 2017, FDA published a proposed order in the Federal 
Register to reclassify the device (82 FR 57174) (the ``proposed 
order''). The period for public comment on the proposed order closed on 
February 2, 2018. FDA received and has considered 78 comments on the 
proposed order, as discussed in section II.

II. Comments on the Proposed Order and FDA Response

A. Introduction

    FDA received 78 public comments in response to the December 4, 
2017, proposed order. These comments originated from individual 
consumers, academia, healthcare professionals, healthcare associations, 
local governments, and industry. The overwhelming majority of 
commenters supported the proposed reclassification, name change, and 
the general effort to increase patient access to single-use internal 
condoms.
    We describe and respond to the comments in section B, below. The 
order of response to the commenters is purely for organizational 
purposes and does not signify the comment's value or importance nor the 
order in which comments were received. Certain comments are grouped 
together under a single number because the subject matter is similar.

B. Description of Comments and FDA Response

    (Comment 1) Several commenters supported the reclassification and 
name change, but did not think a contraceptive effectiveness study 
should be required as a special control. These commenters believe that 
an acute failure modes study would be sufficient to ensure the safety 
and effectiveness of single-use internal condoms. The commenters 
indicated that requiring a contraceptive effectiveness study is 
burdensome and that the contraceptive effectiveness rate of a 
previously approved internal condom (FC1 Female Condom) should be 
leveraged in lieu of this special control. Another commenter suggested 
that single-use internal condoms be evaluated based on data from an 
acute failure modes study because this is the clinical evidence used to 
support clearance of male condoms made of synthetic materials. Finally, 
a different commenter agreed with FDA that there are unique 
considerations for the female condom, and that FDA should carefully 
consider each single-use internal condom to determine the appropriate 
method for clinical validation. The commenter noted that the majority 
of clinical studies published worldwide are conducted using male 
condoms, and that analysis by FDA, National Institutes of Health, and 
the Centers for Disease Control and Prevention re-confirmed the safety 
and effectiveness of male condoms. This commenter recommended that FDA 
consider developing a medical device development tool to find less 
burdensome ways of evaluating internal condom effectiveness using 
biomarkers.
    (Response 1) While the probable risks to health and risk 
mitigations are similar between male and single-use internal condoms, 
the failure modes are not the same between these two types of condoms. 
Male condoms have failure modes from slippage and breakage, while 
single-use internal condoms have failure modes that include slippage, 
breakage, misdirection, and invagination. FDA believes that a 
contraceptive effectiveness study is necessary to mitigate the risk of 
an undesired pregnancy because internal condoms have distinct design 
features from male condoms (e.g., internal and external retaining 
mechanisms) and from other internal condoms that can only be evaluated 
through a contraceptive effectiveness study. Accordingly, FDA believes 
that the clinical evidence from male condoms and other internal condoms 
cannot be leveraged to mitigate the risk of undesired pregnancy for an 
individual single-use internal condom. The contraceptive effectiveness 
rate of an individual internal condom is important because internal 
condoms are intended for the prevention of pregnancy, and this 
contraceptive effectiveness rate is important for consumers when 
deciding which method of contraception is most appropriate for them. 
FDA is not aware of any information, and none was provided to the 
docket, supporting that a biomarker method could be used in lieu of a 
contraceptive effectiveness study.
    (Comment 2) One commenter generally agreed with FDA's proposed 
reclassification, name change, and the proposed special controls for 
single-use internal condoms. This commenter stated that, in addition to 
FDA's proposed special controls, a pre-clearance good manufacturing 
practices (GMP) inspection should be required under section 513(f)(5) 
of the FD&C Act.
    (Response 2) FDA may withhold 510(k) clearance under section 
513(f)(5) of the FD&C Act if there is a substantial likelihood that 
failure to comply with GMPs will potentially present a serious risk to 
human health. FDA does not believe the threshold for pre-clearance GMP 
inspections is met for single-use internal condoms. Single-use internal 
condoms will be required to comply with GMPs under the quality system 
regulation per 21 CFR part 820 that will, in part, mitigate the 
identified probable risks to health. FDA believes that the special 
controls identified in this final order, in addition to general 
controls, including compliance with GMPs, will provide reasonable 
assurance of safety and effectiveness for single-use internal condoms.
    (Comment 3) Multiple commenters requested that FDA not change 
contraceptive coverage policies for single-use internal condoms.
    (Response 3) Contraceptive coverage policies by private insurance 
payers and the Centers for Medicare & Medicaid Services are outside the 
scope of FDA's reclassification process. FDA is required to classify 
devices based on the regulatory controls necessary to provide 
reasonable assurance of device safety and effectiveness. FDA believes 
that sufficient information exists to establish special controls that, 
in addition to general controls, can provide reasonable assurance of 
safety and effectiveness for single-use internal condoms.

[[Page 48713]]

    (Comment 4) Several comments received were related to consumer 
access and education. One commenter expressed concerns that consumers 
``believe that all medical-like devices that are placed on the shelves 
have been reviewed and tested.'' Based on safety and effectiveness 
information provided to the docket, the commenter believes that more 
attention should be geared towards educating consumers on the proper 
use and effectiveness of single-use internal condoms. Conversely, 
several different commenters stated that single-use internal condoms 
should be made over-the-counter (OTC) devices.
    (Response 4) The single-use internal condom is not restricted to 
prescription use in accordance with 21 CFR 801.109. Single-use internal 
condoms are OTC devices because FDA believes that adequate directions 
for lay use can be developed in accordance with 21 CFR 801.5. Adequate 
directions for use are those under which the layman can use a device 
safely and for the purposes for which it is intended. This information 
helps consumers understand how to appropriately use the device and make 
informed decisions regarding its use. While the devices are OTC, 
single-use internal condoms will be subject to FDA premarket review in 
accordance with section 510(k) of the FD&C Act. In accordance with 
section 513(i) of the FD&C Act, FDA reviews appropriate clinical or 
scientific data as part of the substantial equivalence determination.
    (Comment 5) One commenter stated that single-use internal condoms 
should be class III ``based on medical evidence of its effectiveness in 
disease prevention as well as a safe and effective family planning 
method.'' The commenter believed that the reclassification is not based 
on science, that the reclassification is based on a political stance on 
birth control, and that science should be the only reason for 
reclassification. Three commenters included a combination of scientific 
literature, marketing data, non-public clinical data, and anecdotal 
information on one single-use internal condom used in the United States 
and another used outside the United States as additional evidence in 
support of FDA's reclassification.
    (Response 5) FDA is only authorized to use valid scientific 
evidence to support device reclassification, in accordance with 
513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). The commenter not 
supportive of the proposed reclassification did not provide specific 
information or rationales regarding why FDA's proposal to reclassify 
was not based on valid scientific evidence. As outlined in the proposed 
order, sufficient valid scientific evidence exists to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness for single-use internal condoms, despite these condoms 
being for a use which is of substantial importance in preventing 
impairment of human health. Therefore, FDA believes that single-use 
internal condoms meet the statutory definition of class II (special 
controls).
    (Comment 6) One commenter requested clarification regarding 
differences in how male condoms are regulated in comparison to single-
use internal condoms.
    (Response 6) A male condom is comprised of a sheath which 
completely covers the penis with a closely fitting membrane. Male 
condoms are regulated under 21 CFR 884.5300 and are class II (special 
controls). As of the effective date of this reclassification order, 
single-use internal condoms are class II (special controls). FDA has 
identified distinct special controls for single-use internal condoms 
because they have different failure modes due to differences in 
technological characteristics compared to male condoms.

III. The Final Order

    FDA is adopting its findings under section 513(f)(3) of the FD&C 
Act, as published in the preamble to the proposed order (82 FR 57174). 
FDA is issuing this final order to reclassify single-use female condoms 
from class III to class II, rename them ``single-use internal 
condoms,'' and establish special controls by revising 21 CFR part 884. 
In this final order, the Agency has identified the special controls 
under section 513(a)(1)(B) of the FD&C Act that, together with general 
controls, provide a reasonable assurance of the safety and 
effectiveness for single-use internal condoms. FDA is also amending the 
existing device identification for female condoms to distinguish them 
from single-use internal condoms, by renaming the device ``multiple-use 
female condom.'' The Agency is making two minor modifications to the 
identification for single-use internal condoms by confirming that they 
are OTC devices and that the device is intended to ``prevent the 
transmission of sexually transmitted infections,'' not ``prevent 
sexually transmitted infections.''
    FDA may exempt a class II device from the premarket notification 
requirements, under section 510(m) 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 devices. FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness of single-use internal 
condoms, and therefore, this device type is not exempt from premarket 
notification requirements.
    The device is assigned the generic name single-use internal condom, 
and it is identified as an OTC 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 
(preventing the transmission of sexually transmitted infections) 
purposes.
    Under this final order, the single-use internal condom is an OTC 
device. OTC devices must bear adequate directions for lay use as 
outlined in 21 CFR 801.5. Under 21 CFR 807.81, the device would 
continue to be subject to 510(k) requirements.

IV. Analysis of Environmental Impact

    We have 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.

V. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
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 21 CFR part 807, subpart E, have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
814, subparts A through E, have been approved under OMB control number 
0910-0231; the collections of information in 21 CFR part 820 have been 
approved under OMB control number 0910-0073; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

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, 21 CFR part 
884 is amended as follows:

[[Page 48714]]

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 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 to subpart F to read as follows:


Sec.  884.5340  Single-use internal condom.

    (a) Identification. A single-use internal condom is an over-the-
counter 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 (preventing the transmission 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; and
    (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: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21044 Filed 9-26-18; 8:45 am]
 BILLING CODE 4164-01-P