[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
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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
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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