[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Rules and Regulations]
[Pages 7993-7995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2019-N-0138]


Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Software Application for Contraception

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the software application for contraception 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 
the software application for contraception's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) 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.

DATES: This order is effective March 6, 2019. The classification was 
applicable on August 10, 2018.

FOR FURTHER INFORMATION CONTACT: Paige Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G627, Silver Spring, MD 20993-0002, 301-796-6417, 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 7994]]

I. Background

    Upon request, FDA has classified the software application for 
contraception as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. 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 as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate 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. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 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 shall 
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 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 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application (PMA) in order to market a 
substantially equivalent device (see 21 U.S.C. 360c(i), defining 
``substantial equivalence''). Instead, sponsors can use the 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on August 28, 2017, finding 
Natural Cycles not substantially equivalent to a predicate not subject 
to PMA. Thus, the device remained in class III in accordance with 
section 513(f)(1) of the FD&C Act when we issued the order.
    On September 20, 2017, Natural Cycles Nordic AB submitted a request 
for De Novo classification of Natural Cycles. 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, 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 21 U.S.C. 360c(a)(1)(B)). 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 August 10, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 884.5370. We have named 
the generic type of device software application for contraception, and 
it is identified as a device that provides user-specific fertility 
information for preventing a pregnancy. This device includes an 
algorithm that performs analysis of patient-specific data (e.g., 
temperature, menstrual cycle dates) to distinguish between fertile and 
non-fertile days, then provides patient-specific recommendations 
related to contraception.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

  Table 1--Software Application for Contraception Risks and Mitigation
                                Measures
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         Identified risks                    Mitigation measures
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Unintended pregnancy..............  Software verification, validation,
                                     and hazard analysis; clinical
                                     performance testing; human factors
                                     and usability testing; and
                                     labeling.
------------------------------------------------------------------------

    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. In order 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 order. This device is 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 individually or cumulatively 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

[[Page 7995]]

Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3520). The collections of information in the 
guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in part 820, regarding 
design controls, have been approved under OMB control number 0910-0073; 
the collections of information in 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; and the collections of information 
in 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.  884.5370 to subpart F to read as follows:


Sec.  884.5370  Software application for contraception.

    (a) Identification. A software application for contraception is a 
device that provides user-specific fertility information for preventing 
a pregnancy. This device includes an algorithm that performs analysis 
of patient-specific data (e.g., temperature, menstrual cycle dates) to 
distinguish between fertile and non-fertile days, then provides 
patient-specific recommendations related to contraception.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the contraceptive 
effectiveness of the software in the intended use population.
    (2) Human factors performance evaluation must be provided to 
demonstrate that the intended users can self-identify that they are in 
the intended use population and can correctly use the application, 
based solely on reading the directions for use for contraception.
    (3) Software verification, validation, and hazard analysis must be 
performed. Documentation must include the following:
    (i) A cybersecurity vulnerability and management process to assure 
software functionality; and
    (ii) A description of the technical parameters of the software, 
including the algorithm used to determine fertility status and alerts 
for user inputs outside of expected ranges.
    (4) Labeling must include:
    (i) The following warnings and precautions:
    (A) A statement that no contraceptive method is 100% effective.
    (B) A statement that another form of contraception (or abstinence) 
must be used on days specified by the application.
    (C) Statements of any factors that may affect the accuracy of the 
contraceptive information.
    (D) A warning that the application cannot protect against sexually 
transmitted infections.
    (ii) Hardware platform and operating system requirements.
    (iii) Instructions identifying and explaining how to use the 
software application, including required user inputs and how to 
interpret the application outputs.
    (iv) A summary of the clinical validation study and results, 
including effectiveness of the application as a stand-alone 
contraceptive and how this effectiveness compares to other forms of 
legally marketed contraceptives.

    Dated: February 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04028 Filed 3-5-19; 8:45 am]
BILLING CODE 4164-01-P