Rule2026-09152
Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 8, 2026
Effective
May 8, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external condom for anal intercourse or vaginal intercourse. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 89 (Friday, May 8, 2026)</title>
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[Federal Register Volume 91, Number 89 (Friday, May 8, 2026)]
[Rules and Regulations]
[Pages 25109-25112]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA-2026-N-4659]
Medical Devices; Obstetrical and Gynecological Devices;
Classification of the External Condom for Anal Intercourse or Vaginal
Intercourse
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
external condom for anal intercourse or vaginal intercourse into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for classification of the external condom for anal intercourse
or vaginal intercourse. We are taking this action because we have
determined that classifying the device into class II will provide a
reasonable assurance of safety and effectiveness of the device. We
believe this action will also enhance patients' access to beneficial
innovative devices, in part by reducing regulatory burdens.
[[Page 25110]]
DATES: This order is effective May 8, 2026. The classification was
applicable on February 23, 2022.
FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-796-6529,
<a href="/cdn-cgi/l/email-protection#de8db6bfacb1b0f09fb0baacbba9ad9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="87d4efe6f5e8e9a9c6e9e3f5e2f0f4c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the external
condom for anal intercourse or vaginal intercourse into class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness of the device. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On December 9, 2021, FDA received Global Protection Corp.'s request
for De Novo classification of the ONE Male Condom. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on February 23, 2022, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
884.5305.\1\ We have named the generic type of device ``external condom
for anal intercourse or vaginal intercourse,'' and it is identified as
a barrier device which covers the penis and is used to prevent the
transmission of sexually transmitted infections (when used for anal
intercourse or vaginal intercourse) and for contraception (when used
for vaginal intercourse). This classification does not include condoms
intended for vaginal intercourse only.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
[[Page 25111]]
Table 1--Risks to Health and Mitigation Measures for External Condom for
Anal Intercourse or Vaginal Intercourse
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Identified risks to health Mitigation measures
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Transmission of sexually transmitted Acute failure modes clinical
infection. study; Non-clinical
performance testing; Shelf
life testing; and Labeling.
Pregnancy.............................. Acute failure modes clinical
study; Non-clinical
performance testing; Shelf
life testing; and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation;
and Labeling.
Mechanical injury leading to Acute failure modes clinical
ulceration, laceration, trauma. study; Non-clinical
performance testing; Shelf
life testing; and Labeling.
Use error/improper device use leading Acute failure modes clinical
to the risks above. study; and Labeling.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for external condoms for anal
intercourse or vaginal intercourse. This device is therefore subject to
premarket notification requirements under section 510(k) of the FD&C
Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 820
regarding quality management system regulation have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 regarding labeling 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:
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. Add Sec. 884.5305 to subpart F to read as follows:
Sec. 884.5305 External condom for anal intercourse or vaginal
intercourse.
(a) Identification. An external condom for anal intercourse or
vaginal intercourse is a barrier device which covers the penis and is
used to prevent the transmission of sexually transmitted infections
(when used for anal intercourse or vaginal intercourse) and for
contraception (when used for vaginal intercourse). This classification
does not include condoms intended for vaginal intercourse only.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance data must demonstrate the total rate of
clinical failure and rate of individual failure modes of the device
based on an acute failure modes study.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
data must include an assessment of mechanical and material integrity,
including an evaluation of device failure modes. For devices made of
materials other than natural rubber latex, viral penetration testing
must be conducted to evaluate barrier effectiveness to sexually
transmitted infections.
(3) The device must be demonstrated to be biocompatible.
(4) Performance data must support the shelf life of the device by
demonstrating device functionality and package integrity over the
identified shelf life.
(5) Labeling must include:
(i) If indicated for vaginal intercourse, a contraceptive
effectiveness table comparing typical use and perfect use pregnancy
rates with the device to other available methods of birth control;
(ii) Statement regarding compatibility with additional lubricant
types;
(iii) Statement regarding the adverse events associated with the
device, including transmission of infection, pregnancy, adverse tissue
reaction, mechanical injury, or improper device use;
(iv) Expiration date; and
(v) The following information, warnings and precautions:
(A) The sexually transmitted infections (STIs) for which the device
is most protective, the degree of protection the device provides
against specific types of STIs, and the STIs the device does not
protect against;
(B) A statement that the device does not completely eliminate the
risks of pregnancy and sexually transmitted infections and that risk
can be decreased with correct and consistent use;
(C) A warning regarding the risk of device failure during anal
intercourse if adequate lubricant is not used;
(D) A warning stating that the device cannot be used multiple times
and is limited to one sex act; and
[[Page 25112]]
(E) A precaution stating not to use the device if the user is at
risk for material related allergic reactions.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09152 Filed 5-7-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 8, 2026.
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