[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Rules and Regulations]
[Pages 61446-61448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-6842]


Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Pressure Wedge for the Reduction of Cesarean 
Delivery

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 pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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 December 28, 2017. The classification 
was applicable on December 19, 2016.

FOR FURTHER INFORMATION CONTACT: Mack Hall III, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993-0002, 301-796-5621, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the pressure wedge for the 
reduction of cesarean delivery 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

[[Page 61447]]

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 and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 (21 U.S.C. 360c(f)(2)). 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 (21 U.S.C. 360c(a)(1)). 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 PMA in order to market a substantially equivalent device (see 21 
U.S.C. 360c(i), defining ``substantial equivalence''). Instead, 
sponsors can use the less-burdensome 510(k) process, when necessary, to 
market their device.

II. De Novo Classification

    On January 29, 2016, Stetrix, Inc., submitted a request for De Novo 
classification of the Hem-Avert[supreg] Perianal Stabilizer. 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 December 19, 2016, 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 884.5210. We have named 
the generic type of device pressure wedge for the reduction of cesarean 
delivery, and it is identified as a prescription device that provides 
external mechanical support to the perianal region during the labor and 
vaginal delivery process. External mechanical support of the perianal 
region is intended to help reduce the occurrence of cesarean delivery.
    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--Pressure Wedge for the Reduction of Cesarean Delivery Risks and
                           Mitigation Measures
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            Identified risk                    Mitigation measures
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Skin/tissue trauma.....................  Non-clinical performance data,
                                          Clinical performance data, and
                                          Labeling.
Device failure.........................  Non-clinical performance data
                                          and Labeling.
     Breakage..................
     Slippage..................
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Pain...................................  Labeling.
Use error..............................  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).
    At the time of classification, pressure wedge for the reduction of 
cesarean delivery is for prescription use only. Prescription devices 
are exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as 
long as the conditions of 21 CFR 801.109 are met (referring to 21 
U.S.C. 352(f)(1)).

[[Page 61448]]

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. 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 
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 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 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.  884.5210 to subpart F to read as follows:


Sec.  884.5210   Pressure wedge for the reduction of cesarean delivery.

    (a) Identification. A pressure wedge for the reduction of cesarean 
delivery is a prescription device that provides external mechanical 
support to the perianal region during the labor and vaginal delivery 
process. External mechanical support of the perianal region is intended 
to help reduce the occurrence of cesarean delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be evaluated to be 
biocompatible.
    (2) Nonclinical performance data must demonstrate that the device 
will not break when subjected to the forces it will be exposed to 
during labor.
    (3) Performance data must validate the sterility of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility and package integrity over the 
labeled shelf life.
    (5) Clinical performance data must be provided that characterizes 
the rate of skin/tissue trauma.
    (6) The labeling must include:
    (i) Specific instructions regarding the proper placement and use of 
the device.
    (ii) A shelf life.

    Dated: December 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28042 Filed 12-27-17; 8:45 am]
 BILLING CODE 4164-01-P