[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

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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

[[Page 3545]]

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