Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test, 27699-27702 [2018-12760]
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
§ 725.717 What are the time limitations for
requesting payment or reimbursement for
covered medical services or treatments?
§ 725.716 How should a miner prepare and
submit requests for reimbursement for
covered medical expenses and
transportation costs?
daltland on DSKBBV9HB2PROD with RULES
including the limitation imposed on the
amount to be paid.
OWCP will pay providers and
reimburse miners promptly for all bills
received on an approved form and in a
timely manner. However, absent good
cause, no bill will be paid for expenses
incurred if the bill is submitted more
than one year beyond the end of the
calendar year in which the expense was
incurred or the service or supply was
provided, or more than one year beyond
the end of the calendar year in which
the miner’s eligibility for benefits is
finally adjudicated, whichever is later.
A provider may not request
reimbursement from a miner for a bill
denied by OWCP due to late submission
of the bill by the provider.
(a) If a miner has paid bills for a
medical service or treatment covered
under § 725.701 and seeks
reimbursement for those expenses, he or
she may submit a request for
reimbursement on Form OWCP–915,
together with an itemized bill. The
reimbursement request must be
accompanied by evidence that the
provider received payment for the
service from the miner and a statement
of the amount paid. Acceptable
evidence that payment was received
includes, but is not limited to, a copy
of the miner’s canceled check (both
front and back) or a copy of the miner’s
credit card receipt.
(b) OWCP may waive the
requirements of paragraph (a) of this
section if extensive delays in the filing
or the adjudication of a claim make it
unusually difficult for the miner to
obtain the required information.
(c) Reimbursements for covered
medical services paid by a miner
generally will be no greater than the
maximum allowable charge for such
service as determined under
§§ 725.707–725.711.
(d) A miner will be only partially
reimbursed for a covered medical
service if the amount he or she paid to
a provider for the service exceeds the
maximum charge allowable. If this
happens, OWCP will advise the miner
of the maximum allowable charge for
the service in question and of his or her
responsibility to ask the provider to
refund to the miner, or credit to the
miner’s account, the amount he or she
paid which exceeds the maximum
allowable charge.
(e) If the provider does not refund to
the miner or credit to his or her account
the amount of money paid in excess of
the charge allowed by OWCP, the miner
should submit documentation to OWCP
of the attempt to obtain such refund or
credit. OWCP may make reasonable
reimbursement to the miner after
reviewing the facts and circumstances of
the case.
(f) If a miner has paid transportation
costs or other incidental expenses
related to covered medical services
under this part, the miner may submit
a request for reimbursement on Form
OWCP–957 or OWCP–915, together
with proof of payment.
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§ 725.718 How are disputes concerning
medical benefits resolved?
(a) If a dispute develops concerning
medical services or treatments or their
payment under this part, OWCP must
attempt to informally resolve the
dispute. OWCP may, on its own
initiative or at the request of the
responsible operator or its insurance
carrier, order the claimant to submit to
an examination by a physician selected
by OWCP.
(b) If a dispute cannot be resolved
informally, OWCP will refer the case to
the Office of Administrative Law Judges
for a hearing in accordance with this
part. Any such hearing concerning
authorization of medical services or
treatments must be scheduled at the
earliest possible time and must take
precedence over all other hearing
requests except for other requests under
this section and as provided by
§ 727.405 of this subchapter (see
§ 725.4(d)). During the pendency of such
adjudication, OWCP may order the
payment of medical benefits prior to
final adjudication under the same
conditions applicable to benefits
awarded under § 725.522.
(c) In the development or adjudication
of a dispute over medical benefits, the
adjudication officer is authorized to take
whatever action may be necessary to
protect the health of a totally disabled
miner.
(d) Any interested medical provider
may, if appropriate, be made a party to
a dispute under this subpart.
§ 725.719 What is the objective of
vocational rehabilitation?
The objective of vocational
rehabilitation is the return of a miner
who is totally disabled by
pneumoconiosis to gainful employment
commensurate with such miner’s
physical impairment. This objective
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27699
may be achieved through a program of
re-evaluation and redirection of the
miner’s abilities, or retraining in another
occupation, and selective job placement
assistance.
§ 725.720 How does a miner request
vocational rehabilitation assistance?
Each miner who has been determined
entitled to receive benefits under part C
of title IV of the Act must be informed
by OWCP of the availability and
advisability of vocational rehabilitation
services. If such miner chooses to avail
himself or herself of vocational
rehabilitation, his or her request will be
processed and referred by OWCP
vocational rehabilitation advisors
pursuant to the provisions of §§ 702.501
through 702.508 of this chapter as is
appropriate.
Dated: June 5, 2018.
Julia K. Hearthway,
Director, Office of Workers’ Compensation
Programs.
[FR Doc. 2018–12418 Filed 6–13–18; 8:45 am]
BILLING CODE 4510–CR–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2018–N–1928]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Brain Trauma Assessment Test
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the brain trauma assessment
test 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
brain trauma assessment test’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 June 14,
2018. The classification was applicable
on February 14, 2018.
FOR FURTHER INFORMATION CONTACT: Erin
Cutts, Center for Devices and
Radiological Health, Food and Drug
SUMMARY:
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5618, Silver Spring,
MD 20993–0002, 301–796–6307,
erin.cutts@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
brain trauma assessment test 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 (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 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 August 28, 2017, Banyan
Biomarkers, Inc., submitted a request for
De Novo classification of the Banyan
BTI. 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 February 14, 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 866.5830. We
have named the generic type of device
brain trauma assessment test, and it is
identified as a device that consists of
reagents used to detect and measure
brain injury biomarkers in human
specimens. The measurements aid in
the evaluation of patients with
suspected mild traumatic brain injury in
conjunction with other clinical
information to assist in determining the
need for head imaging per current
standard of care.
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—BRAIN TRAUMA ASSESSMENT TEST RISKS AND MITIGATION MEASURES
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Identified risks
Mitigation measures
Inaccurate test results that provide false positive or false negative results.
Failure to correctly interpret test results can lead to false positive or
false negative results.
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
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General controls and special control (1) (21 CFR 866.5830(b)(1)).
General controls and special control (2) (21 CFR 866.5830(b)(2)).
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
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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
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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
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
parts 801 and 809, regarding labeling,
have been approved under OMB control
number 0910–0485.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, 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 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.5830 to subpart F to read
as follows:
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■
§ 866.5830
Brain trauma assessment test.
(a) Identification. A brain trauma
assessment test is a device that consists
of reagents used to detect and measure
brain injury biomarkers in human
specimens. The measurements aid in
the evaluation of patients with
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suspected mild traumatic brain injury in
conjunction with other clinical
information to assist in determining the
need for head imaging per current
standard of care.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The 21 CFR 809.10(b) compliant
labeling must include detailed
descriptions of and results from
performance testing conducted to
evaluate precision, accuracy, linearity,
analytical sensitivity, interference, and
cross-reactivity. This information must
include the following:
(i) Performance testing of device
precision must, at minimum, use one
unmodified clinical specimen from the
intended use population with
concentration of the brain injury
biomarker(s) near the medical decision
point. Contrived specimens that have
been generated from pooling of multiple
samples or spiking of purified analyte to
cover the measuring range may be used,
but the contrived samples must be
prepared to mimic clinical specimens as
closely as possible. This testing must
evaluate repeatability and
reproducibility using a protocol from an
FDA-recognized standard.
(ii) Device performance data must be
demonstrated through a clinical study
and must include the following:
(A) Data demonstrating clinical
validity including the clinical
sensitivity and specificity, and positive
and negative predictive value of the test
in the intended use population of
patients with suspected mild traumatic
brain injury (i.e., Glasgow Coma Score
(GCS) of 13–15), or equivalent standard
of care for determination of severity of
traumatic brain injury (TBI).
(B) Study must be performed using
the operators and in settings that are
representative of the types of operators
and settings for which the device is
intended to be used.
(C) All eligible subjects must meet the
well-defined study inclusion and
exclusion criteria that define the
intended use population. The
prevalence of diseased or injured
subjects in the study population must
reflect the prevalence of the device’s
intended use population, or
alternatively, statistical measures must
be used to account for any bias due to
enrichment of subpopulations of the
intended use population.
(D) All eligible subjects must have
undergone a head computerized
tomography (CT) scan or other
appropriate clinical diagnostic standard
used to determine the presence of an
intracranial lesion as part of standard of
care and must also be evaluated by the
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27701
subject device. All clinical diagnostic
standards used in the clinical study
must follow standard clinical practice in
the United States.
(E) Relevant demographic variables
and baseline characteristics including
medical history and neurological
history. In addition, head injury
characteristics, neurological
assessments, and physical evidence of
trauma must be provided for each
subject. This information includes but is
not limited to the following: Time since
head injury, time from head injury to CT
scan, time from head injury to blood
draw, GCS score or equivalent,
experience of loss of consciousness,
presence of confusion, episodes of
vomiting, post-traumatic amnesia
characteristics, presence of posttraumatic seizures, drug or alcohol
intoxication, mechanism of injury, acute
intracranial lesion type, neurosurgical
lesion, and cranial fracture.
(F) Each CT scan or other imaging
result must be independently evaluated
in a blinded manner by at least two
board-certified radiologists to determine
whether it is positive or negative as
defined by the presence or absence of
acute intracranial lesions. This
independent review must be conducted
without access to test results of the
device. Prior to conducting the review,
the criteria and procedures to be
followed for scoring the images must be
established, including the mechanism
for determining consensus.
(G) All the clinical samples must be
tested with the subject device blinded to
the TBI status and the neurologicallesion-status of the subject.
(H) Details on how missing values in
data are handled must be provided.
(I) For banked clinical samples,
details on storage conditions and storage
period must be provided. In addition, a
specimen stability study must be
conducted for the duration of storage to
demonstrate integrity of archived
clinical samples. The samples evaluated
in the assay test development must not
be used to establish the clinical validity
of the assays.
(iii) Performance testing of device
analytical specificity must include the
most commonly reported concomitant
medications present in specimens from
the intended use population.
Additionally, potential cross-reacting
endogenous analytes must be evaluated
at the highest concentration reported in
specimens from the intended use
population.
(iv) Expected/reference values
generated by testing a statistically
appropriate number of samples from
apparently healthy normal individuals.
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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
(2) The 21 CFR 809.10(a) and (b)
compliant labeling must include the
following limitations:
(i) A limiting statement that this
device is not intended to be used a
stand-alone device but as an adjunct to
other clinical information to aid in the
evaluation of patients who are being
considered for standard of care
neuroimaging.
(ii) A limiting statement that reads ‘‘A
negative result is generally associated
with the absence of acute intracranial
lesions. An appropriate neuroimaging
method is required for diagnosis of
acute intracranial lesions.’’
(iii) As applicable, a limiting
statement that reads ‘‘This device is for
use by laboratory professionals in a
clinical laboratory setting.’’
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12760 Filed 6–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2018–N–1862]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Endoscopic Electrosurgical Clip
Cutting System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the endoscopic
electrosurgical clip cutting system 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
endoscopic electrosurgical clip cutting
system’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 June 14,
2018. The classification was applicable
on December 22, 2017.
FOR FURTHER INFORMATION CONTACT:
Purva Pandya, Center for Devices and
Radiological Health, Food and Drug
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SUMMARY:
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Jkt 244001
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G223, Silver Spring,
MD 20993–0002, 240–402–9979,
Purva.Pandya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
endoscopic electrosurgical clip cutting
system 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),
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
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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. 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 lessburdensome 510(k) process, when
necessary, to market their device.
II. De Novo Classification
On April 11, 2016, Ovesco Endoscopy
AG submitted a request for De Novo
classification of the remOVE System.
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.
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]]>Agencies
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27699-27702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12760]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2018-N-1928]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Brain Trauma Assessment Test
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the brain trauma assessment test 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 brain trauma
assessment test'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 June 14, 2018. The classification was
applicable on February 14, 2018.
FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and
Radiological Health, Food and Drug
[[Page 27700]]
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5618, Silver
Spring, MD 20993-0002, 301-796-6307, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the brain trauma assessment test
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 (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 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 August 28, 2017, Banyan Biomarkers, Inc., submitted a request
for De Novo classification of the Banyan BTI. 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 February 14, 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 866.5830. We have named
the generic type of device brain trauma assessment test, and it is
identified as a device that consists of reagents used to detect and
measure brain injury biomarkers in human specimens. The measurements
aid in the evaluation of patients with suspected mild traumatic brain
injury in conjunction with other clinical information to assist in
determining the need for head imaging per current standard of care.
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--Brain Trauma Assessment Test Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Inaccurate test results that provide General controls and special
false positive or false negative control (1) (21 CFR
results. 866.5830(b)(1)).
Failure to correctly interpret test General controls and special
results can lead to false positive or control (2) (21 CFR
false negative results. 866.5830(b)(2)).
------------------------------------------------------------------------
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
[[Page 27701]]
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 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
parts 801 and 809, regarding labeling, have been approved under OMB
control number 0910-0485.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, 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
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.5830 to subpart F to read as follows:
Sec. 866.5830 Brain trauma assessment test.
(a) Identification. A brain trauma assessment test is a device that
consists of reagents used to detect and measure brain injury biomarkers
in human specimens. The measurements aid in the evaluation of patients
with suspected mild traumatic brain injury in conjunction with other
clinical information to assist in determining the need for head imaging
per current standard of care.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The 21 CFR 809.10(b) compliant labeling must include detailed
descriptions of and results from performance testing conducted to
evaluate precision, accuracy, linearity, analytical sensitivity,
interference, and cross-reactivity. This information must include the
following:
(i) Performance testing of device precision must, at minimum, use
one unmodified clinical specimen from the intended use population with
concentration of the brain injury biomarker(s) near the medical
decision point. Contrived specimens that have been generated from
pooling of multiple samples or spiking of purified analyte to cover the
measuring range may be used, but the contrived samples must be prepared
to mimic clinical specimens as closely as possible. This testing must
evaluate repeatability and reproducibility using a protocol from an
FDA-recognized standard.
(ii) Device performance data must be demonstrated through a
clinical study and must include the following:
(A) Data demonstrating clinical validity including the clinical
sensitivity and specificity, and positive and negative predictive value
of the test in the intended use population of patients with suspected
mild traumatic brain injury (i.e., Glasgow Coma Score (GCS) of 13-15),
or equivalent standard of care for determination of severity of
traumatic brain injury (TBI).
(B) Study must be performed using the operators and in settings
that are representative of the types of operators and settings for
which the device is intended to be used.
(C) All eligible subjects must meet the well-defined study
inclusion and exclusion criteria that define the intended use
population. The prevalence of diseased or injured subjects in the study
population must reflect the prevalence of the device's intended use
population, or alternatively, statistical measures must be used to
account for any bias due to enrichment of subpopulations of the
intended use population.
(D) All eligible subjects must have undergone a head computerized
tomography (CT) scan or other appropriate clinical diagnostic standard
used to determine the presence of an intracranial lesion as part of
standard of care and must also be evaluated by the subject device. All
clinical diagnostic standards used in the clinical study must follow
standard clinical practice in the United States.
(E) Relevant demographic variables and baseline characteristics
including medical history and neurological history. In addition, head
injury characteristics, neurological assessments, and physical evidence
of trauma must be provided for each subject. This information includes
but is not limited to the following: Time since head injury, time from
head injury to CT scan, time from head injury to blood draw, GCS score
or equivalent, experience of loss of consciousness, presence of
confusion, episodes of vomiting, post-traumatic amnesia
characteristics, presence of post-traumatic seizures, drug or alcohol
intoxication, mechanism of injury, acute intracranial lesion type,
neurosurgical lesion, and cranial fracture.
(F) Each CT scan or other imaging result must be independently
evaluated in a blinded manner by at least two board-certified
radiologists to determine whether it is positive or negative as defined
by the presence or absence of acute intracranial lesions. This
independent review must be conducted without access to test results of
the device. Prior to conducting the review, the criteria and procedures
to be followed for scoring the images must be established, including
the mechanism for determining consensus.
(G) All the clinical samples must be tested with the subject device
blinded to the TBI status and the neurological-lesion-status of the
subject.
(H) Details on how missing values in data are handled must be
provided.
(I) For banked clinical samples, details on storage conditions and
storage period must be provided. In addition, a specimen stability
study must be conducted for the duration of storage to demonstrate
integrity of archived clinical samples. The samples evaluated in the
assay test development must not be used to establish the clinical
validity of the assays.
(iii) Performance testing of device analytical specificity must
include the most commonly reported concomitant medications present in
specimens from the intended use population. Additionally, potential
cross-reacting endogenous analytes must be evaluated at the highest
concentration reported in specimens from the intended use population.
(iv) Expected/reference values generated by testing a statistically
appropriate number of samples from apparently healthy normal
individuals.
[[Page 27702]]
(2) The 21 CFR 809.10(a) and (b) compliant labeling must include
the following limitations:
(i) A limiting statement that this device is not intended to be
used a stand-alone device but as an adjunct to other clinical
information to aid in the evaluation of patients who are being
considered for standard of care neuroimaging.
(ii) A limiting statement that reads ``A negative result is
generally associated with the absence of acute intracranial lesions. An
appropriate neuroimaging method is required for diagnosis of acute
intracranial lesions.''
(iii) As applicable, a limiting statement that reads ``This device
is for use by laboratory professionals in a clinical laboratory
setting.''
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12760 Filed 6-13-18; 8:45 am]
BILLING CODE 4164-01-P
