Document ID: FDA-2017-N-6484-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator
Posted Date: 2017-12-19T05:00Z

[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60112-60114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-6484]

Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Fetal Head Elevator

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 fetal head elevator 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 fetal head elevator'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 19, 2017. The classification 
was applicable on July 27, 2017.

FOR FURTHER INFORMATION CONTACT: David Birsen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G623, Silver Spring, MD 20993-0002, 240-402-6655, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the fetal head elevator 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

[[Page 60113]]

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 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. 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 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 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 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 November 20, 2015, Safe Obstetrics Systems, Ltd., submitted a 
request for De Novo classification of the Fetal Pillow. 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 July 27, 2017, 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 884.4350. We have named 
the generic type of device fetal head elevator, and it is identified as 
a prescription device consisting of a mechanism that elevates the fetal 
head to facilitate delivery during a Caesarean section.
    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--Fetal Head Elevator Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Fetal injury due to device failure.....  Non-clinical performance
                                          testing, Shelf life testing,
                                          and Labeling.
Maternal injury due to device failure..  Non-clinical performance
                                          testing, Shelf life testing,
                                          and Labeling.
Use error..............................  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. 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.
    At the time of classification, fetal head elevators are 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 (21 U.S.C. 352(f)(1)) 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)).

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

[[Page 60114]]

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 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; 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.  884.4350 to subpart E to read as follows:

Sec.  884.4350   Fetal head elevator.

    (a) Identification. A fetal head elevator is a prescription device 
consisting of a mechanism that elevates the fetal head to facilitate 
delivery during a Caesarean section.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Reliability testing of device deployment and retrieval under 
relevant use conditions must be conducted.
    (ii) Testing of the maximum force applied to the fetal head in an 
anatomic model must be conducted.
    (iii) Testing of uniform application of the elevator mechanism on 
the fetal head must be conducted.
    (5) Labeling must include the following:
    (i) Contraindication for use in the presence of active genital 
infection;
    (ii) Specific instructions regarding the proper placement and use 
of the device; and
    (iii) A shelf life.

    Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27277 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P