3540 Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations 
procedures and air navigation, it is 
certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. 
Environmental Review 
The FAA has determined that the 
actions of modifying the Lansing, MI, 
Class C airspace area by amending the effective hours to coincide with the associated radar approach control facility hours of operation, and establishing Class D airspace at Capital Region International Airport, MI when the associated radar approach control facility is not in operation, have no potential to cause significant environmental impacts. Therefore, because these airspace actions do not change the boundaries, altitudes, or operating requirements of the Lansing, MI, Class C airspace area, they have been categorically excluded from further environmental impact review in accordance with the National Environmental Policy Act (NEPA) and its implementing regulations at 40 CFR parts 1500–1508, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5–6.5a, which categorically excludes from further environmental impact review, rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). In accordance with FAAO 1050.1F, paragraph 5–2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment. 
List of Subjects in 14 CFR Part 71 
Airspace, Incorporation by reference, 
Navigation (air). The Amendment 
In consideration of the foregoing, the 
Federal Aviation Administration 
amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 
■1. The authority citation for part 71 
continues to read as follows: 
Authority: 49 U.S.C. 106(f), 106(g); 40103, 
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 
1959–1963 Comp., p. 389. 
§ 71.1 [Amended] 
■2. The incorporation by reference in 
14 CFR 71.1 of FAA Order 7400.11D, 
Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, is amended as follows: 
Paragraph 4000—Subpart C—Class C 
Airspace. 
* * * * * 
AGL MI C Lansing, MI [Amended] 
Capital Region International Airport, MI 
(Lat. 42°46′43″ N, long. 84°35′10″ W) 
That airspace extending upward from the 
surface to and including 4,900 feet MSL 
within a 5-mile radius of Capital Region International Airport; and that airspace extending upward from 2,100 feet MSL to and including 4,900 feet MSL within a 10- mile radius of Capital Region International Airport. This Class C airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement. 
* * * * * 
Paragraph 5000—Subpart D—Class D 
Airspace. 
* * * * * 
AGL MI D Lansing, MI [New] 
Capital Region International Airport, MI 
(Lat. 42°46′43″ N, long. 84°35′10″ W) 
That airspace extending upward from the 
surface to and including 3,400 feet MSL 
within a 5-mile radius of Capital Region International Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement. 
* * * * * 
Issued in Washington, DC, on January 15, 
2020. 
Scott M. Rosenbloom, Acting Manager, Rules and Regulations 
Group. 
[FR Doc. 2020–00992 Filed 1–21–20; 8:45 am] 
BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 892 
[Docket No. FDA–2019–N–5610] 
Medical Devices; Radiology Devices; 
Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final amendment; final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the radiological computer- assisted diagnostic (CADx) software for lesions suspicious for cancer 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 CADx software for lesions suspicious for cancer’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 July 19, 2017. 
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, ryan.lubert@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
CADx software for lesions suspicious for cancer 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 
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1FDA 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) 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. 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). 
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 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 April 7, 2017, Quantitative 
Insights Inc. submitted a request for De 
Novo classification of the QuantX. 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 19, 2017, 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 892.2060.
1We have named the 
generic type of device radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer, and it is identified as an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user. 
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—R ADIOLOGICAL CAD XSOFTWARE FOR LESIONS SUSPICIOUS FOR CANCER RISKS AND MITIGATION MEASURES  
Identified risk Mitigation measures 
Incorrect lesion(s) characterization leading to false positive results may 
result in incorrect patient management with possible adverse effects 
such as unnecessary treatment, unnecessary additional medical im-aging and/or unnecessary additional diagnostic workup such as bi-opsy.Certain design verification and validation activities identified in special 
control (1) and Certain labeling information identified in special con-trol (2). 
Incorrect lesion(s) characterization leading to false negative results 
may lead to complications, including incorrect diagnosis and delay in disease management.Certain design verification and validation activities identified in special 
control (1) and Certain labeling information identified in special con-trol (2). 
The device could be misused to analyze images from an unintended 
patient population or on images acquired with incompatible imaging hardware or incompatible image acquisition parameters, leading to inappropriate diagnostic information being displayed to the user.Certain design verification and validation activities identified in special 
control (1) and Certain labeling information identified in special con-trol (2). 
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TABLE 1—R ADIOLOGICAL CAD XSOFTWARE FOR LESIONS SUSPICIOUS FOR CANCER RISKS AND MITIGATION MEASURES — 
Continued 
Identified risk Mitigation measures 
Device failure could lead to the absence of results, delay of results or 
incorrect results, which could likewise lead to inaccurate patient as-
sessment.Certain design verification and validation activities identified in special 
control (1) and Certain labeling information identified in special con-trol (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. 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, 
radiological CADx software for lesions suspicious for cancer 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 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; the collections of information in part 820, regarding the quality system regulation, have been approved under OMB control number 0910–0073; and the collections of information in 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 
■1. The authority citation for part 892 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 892.2060 to subpart B to read 
as follows: 
§ 892.2060 Radiological computer-assisted 
diagnostic software for lesions suspicious of cancer. 
(a) Identification. A radiological 
computer-assisted diagnostic software 
for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user. 
(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 image 
analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) A detailed description of pre- 
specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended. 
(iii) Results from performance testing 
protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (e.g., receiver 
operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment. 
(iv) Standalone 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; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity). 
(2) Labeling must include: 
(i) A detailed description of the 
patient population for which the device 
is indicated for use. 
(ii) A detailed description of the 
intended reading protocol. 
(iii) A detailed description of the 
intended user and recommended user training. 
(iv) A detailed description of the 
device inputs and outputs. 
(v) A detailed description of 
compatible imaging hardware and imaging protocols. 
(vi) Warnings, precautions, and 
limitations, including situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality or for 
certain subpopulations), as applicable. 
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1FDA notes that the ‘‘ACTION’’ caption for this 
final order is styled as ‘‘Final amendment; final 
Continued (vii) Detailed instructions for use. 
(viii) A detailed summary of the 
performance testing, including: Test 
methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (e.g., lesion and organ 
characteristics, disease stages, and imaging equipment). 
Dated: January 9, 2020. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2020–00497 Filed 1–21–20; 8:45 am] 
BILLING CODE 4164–01–P 
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. 
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, ryan.lubert@fda.hhs.gov. 
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.
1We have named the 
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