[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Rules and Regulations]
[Pages 3543-3545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 892
[Docket No. FDA-2019-N-5589]
Medical Devices; Radiology Devices; Classification of the
Radiological Computer Aided Triage and Notification Software
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the radiological computer aided triage and notification software 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 radiological computer aided triage and
notification software'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 January 22, 2020. The classification was
applicable on February 13, 2018.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the radiological computer aided
triage and notification software 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 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 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 510(k) process, when necessary, to market their
device.
II. De Novo Classification
On September 29, 2017, Viz.ai, Inc., submitted a request for De
Novo classification of the ContaCT. 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 13, 2018, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
892.2080.\1\ We have named the
[[Page 3544]]
generic type of device radiological computer aided triage and
notification, and it is identified as an image processing device
intended to aid in prioritization and triage of radiological medical
images. The device notifies a designated list of clinicians of the
availability of time sensitive radiological medical images for review
based on computer aided image analysis of those images performed by the
device. The device does not mark, highlight, or direct users' attention
to a specific location in the original image. The device does not
remove cases from a reading queue. The device operates in parallel with
the standard of care, which remains the default option for all cases.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR's) interpretations of the Federal Register
Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9
and parts 21 and 22), and the Document Drafting Handbook.
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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--Radiological Computer Aided Triage and Notification Software
Risks and Mitigation Measures
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Identified risks Mitigation measures
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Failure to prioritize images for review Certain design verification and
with positive findings may result in validation activities
incorrect and/or delayed patient identified in special control
management. (1) and Certain labeling
information identified in
special control (2).
Positive notifications may result in Certain design verification and
deprioritization of review of images validation activities
from other patients. identified in special control
(1) and Certain labeling
information identified in
special control (2).
The device could be misused to analyze Certain design verification and
images from an unintended patient validation activities
population or on images acquired with identified in special control
incompatible imaging hardware or (1) and Certain labeling
incompatible image acquisition information identified in
parameters, leading to inappropriate special control (2).
notifications being displayed to the
user.
Device failure could lead to the Certain design verification and
absence of results, delay of results validation activities
or incorrect results, which could identified in special control
likewise lead to inaccurate patient (1) and Certain labeling
assessment. information identified in
special control (2).
The triage and notification outputs of Certain design verification and
the device are inappropriately used validation activities
for primary interpretation or as an identified in special control
adjunct for diagnosis outside the (1) and Certain labeling
intended use of the device. information identified in
special control (2).
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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).
At the time of classification, radiological computer aided triage
and notification 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.
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. 3501-3521). 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 21 CFR part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 820, regarding quality system regulation, have been approved under
OMB control number 0910-0073; 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 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
892 is amended as follows:
PART 892--RADIOLOGY DEVICES
0
1. The authority citation for part 892 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 892.2080 to subpart B to read as follows:
Sec. 892.2080 Radiological computer aided triage and notification
software.
(a) Identification. Radiological computer aided triage and
notification software is an image processing prescription device
intended to aid in prioritization and triage of radiological medical
images. The device notifies a designated list of clinicians of the
availability of time sensitive radiological medical images for review
based on computer aided image analysis of those images performed by the
device. The device does not mark, highlight, or direct users' attention
to a specific location in the original image. The device does not
remove cases from
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a reading queue. The device operates in parallel with the standard of
care, which remains the default option for all cases.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include:
(i) A detailed description of the notification and triage
algorithms and all underlying image analysis algorithms including, but
not limited to, a detailed description of the algorithm inputs and
outputs, each major component or block, how the algorithm affects or
relates to clinical practice or patient care, and any algorithm
limitations.
(ii) A detailed description of pre-specified performance testing
protocols and dataset(s) used to assess whether the device will provide
effective triage (e.g., improved time to review of prioritized images
for pre-specified clinicians).
(iii) Results from performance testing that demonstrate that the
device will provide effective triage. The performance assessment must
be based on an appropriate measure to estimate the clinical
effectiveness. The test dataset must contain sufficient numbers of
cases from important cohorts (e.g., subsets defined by clinically
relevant confounders, effect modifiers, associated diseases, and
subsets defined by image acquisition characteristics) such that the
performance estimates and confidence intervals for these individual
subsets can be characterized with the device for the intended use
population and imaging equipment.
(iv) Stand-alone performance testing protocols and results of the
device.
(v) Appropriate software documentation (e.g., device hazard
analysis; software requirements specification document; software design
specification document; traceability analysis; description of
verification and validation activities including system level test
protocol, pass/fail criteria, and results).
(2) Labeling must include the following:
(i) A detailed description of the patient population for which the
device is indicated for use;
(ii) A detailed description of the intended user and user training
that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must
include situations in which the device may fail or may not operate at
its expected performance level (e.g., poor image quality for certain
subpopulations), as applicable;
(iv) A detailed description of compatible imaging hardware, imaging
protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test
methods, dataset characteristics, triage effectiveness (e.g., improved
time to review of prioritized images for pre-specified clinicians),
diagnostic accuracy of algorithms informing triage decision, and
results with associated statistical uncertainty (e.g., confidence
intervals), including a summary of subanalyses on case distributions
stratified by relevant confounders, such as lesion and organ
characteristics, disease stages, and imaging equipment.
Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00496 Filed 1-21-20; 8:45 am]
BILLING CODE 4164-01-P