[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Rules and Regulations]
[Pages 15096-15098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07463]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. FDA-2019-N-0647]
Medical Devices; Anesthesiology Devices; Classification of the
Ventilatory Electrical Impedance Tomograph
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 ventilatory electrical impedance tomograph 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 ventilatory electrical impedance tomograph'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 April 15, 2019. The classification was
applicable on December 20, 2018.
FOR FURTHER INFORMATION CONTACT: Deepika Arora Lakhani, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2560, Silver Spring, MD 20993-0002,
301-796-4042, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the ventilatory electrical
impedance tomograph 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 (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 (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
application 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 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
[[Page 15097]]
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 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 510(k) process, when
necessary, to market their device.
II. De Novo Classification
On September 29, 2017, TIMPEL Inc. submitted a request for De Novo
classification of the ENLIGHT 1810. 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 20, 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 868.1505. We have named
the generic type of device ventilatory electrical impedance tomograph,
and it is identified as a prescription non-invasive, non-radiological
ventilatory device that provides an assessment of local impedance
variation within a cross-section of a patient's thorax.
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--Ventilatory Electrical Impedance Tomograph Risks and Mitigation
Measures
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Identified risks Mitigation measure
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Adverse tissue reaction................ Biocompatibility evaluation.
Electromagnetic interference with other Electromagnetic compatibility
devices. testing.
Infection.............................. Reprocessing validation and
Labeling.
Inaccurate images due to either device Software verification,
hardware or software failure/ validation, and hazard
malfunction. analysis; Non-clinical
performance testing; and
Labeling.
Electrical shock injury or thermal Electrical, thermal, and
injury. mechanical safety testing;
Software verification,
validation, and hazard
analysis; Non-clinical
performance testing; 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. 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, ventilatory electrical impedance
tomographs 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
We have 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 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 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; 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 868
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
868 is amended as follows:
[[Page 15098]]
PART 868--ANESTHESIOLOGY DEVICES
0
1. The authority citation for part 868 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 868.1505 to subpart B to read as follows:
Sec. 868.1505 Ventilatory electrical impedance tomograph.
(a) Identification. A ventilatory electrical impedance tomograph is
a prescription non-invasive, non-radiological ventilatory device that
provides an assessment of local impedance variation within a cross-
section of a patient's thorax.
(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) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including the following:
(i) Characterization of device parameters, including signal-to-
noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude
response, position error, and ringing;
(ii) Real time evaluation of local impedance variation;
(iii) Plethysmogram accuracy testing; and
(iv) Use life testing of reusable components.
(3) Performance data must validate reprocessing instructions for
any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and
mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be
performed.
(6) Labeling must include the following:
(i) Guidance for interpretation of the images generated;
(ii) A warning that the device should be removed before use of a
defibrillator, or defibrillator interaction information based on
defibrillator performance testing with the device;
(iii) A use life for any reusable components; and
(iv) Instructions for reprocessing any reusable components.
Dated: April 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07463 Filed 4-12-19; 8:45 am]
BILLING CODE 4164-01-P