Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer, 3540-3543 [2020-00497]

Download as PDF 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 khammond on DSKJM1Z7X2PROD with RULES 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. The authority citation for part 71 continues to read as follows: 21 CFR Part 892 ■ 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 10mile 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 VerDate Sep<11>2014 15:46 Jan 21, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 Food and Drug Administration [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. The Food and Drug Administration (FDA or we) is classifying the radiological computerassisted 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: SUMMARY: 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 E:\FR\FM\22JAR1.SGM 22JAR1 Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations 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. 3541 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 892.2060.1 We 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. khammond on DSKJM1Z7X2PROD with RULES TABLE 1—RADIOLOGICAL CADX SOFTWARE 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 imaging and/or unnecessary additional diagnostic workup such as biopsy. Incorrect lesion(s) characterization leading to false negative results may lead to complications, including incorrect diagnosis and delay in disease management. 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 control (2). 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 VerDate Sep<11>2014 15:46 Jan 21, 2020 Jkt 250001 Certain design verification and validation activities identified in special control (1) and Certain labeling information identified in special control (2). Certain design verification and validation activities identified in special control (1) and Certain labeling information identified in special control (2). 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. E:\FR\FM\22JAR1.SGM 22JAR1 3542 Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations TABLE 1—RADIOLOGICAL CADX SOFTWARE 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 assessment. Certain design verification and validation activities identified in special control (1) and Certain labeling information identified in special control (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. khammond on DSKJM1Z7X2PROD with RULES 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 VerDate Sep<11>2014 15:46 Jan 21, 2020 Jkt 250001 (ii) A detailed description of prespecified 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 List of Subjects in 21 CFR Part 892 be based on appropriate diagnostic Medical devices, Radiation accuracy measures (e.g., receiver protection, X-rays. operator characteristic plot, sensitivity, specificity, predictive value, and Therefore, under the Federal Food, diagnostic likelihood ratio). The test Drug, and Cosmetic Act and under authority delegated to the Commissioner dataset must contain sufficient numbers of cases from important cohorts (e.g., of Food and Drugs, 21 CFR part 892 is subsets defined by clinically relevant amended as follows: confounders, effect modifiers, PART 892—RADIOLOGY DEVICES concomitant diseases, and subsets defined by image acquisition ■ 1. The authority citation for part 892 characteristics) such that the continues to read as follows: performance estimates and confidence Authority: 21 U.S.C. 351, 360, 360c, 360e, intervals of the device for these 360j, 360l, 371. individual subsets can be characterized for the intended use population and ■ 2. Add § 892.2060 to subpart B to read imaging equipment. as follows: (iv) Standalone performance testing § 892.2060 Radiological computer-assisted protocols and results of the device. diagnostic software for lesions suspicious (v) Appropriate software of cancer. documentation (e.g., device hazard (a) Identification. A radiological analysis; software requirements computer-assisted diagnostic software specification document; software design for lesions suspicious of cancer is an specification document; traceability image processing prescription device analysis; and description of verification intended to aid in the characterization and validation activities including of lesions as suspicious for cancer system level test protocol, pass/fail identified on acquired medical images criteria, results, and cybersecurity). such as magnetic resonance, (2) Labeling must include: mammography, radiography, or (i) A detailed description of the computed tomography. The device patient population for which the device characterizes lesions based on features is indicated for use. or information extracted from the (ii) A detailed description of the images and provides information about intended reading protocol. (iii) A detailed description of the the lesion(s) to the user. Diagnostic and patient management decisions are made intended user and recommended user training. by the clinical user. (iv) A detailed description of the (b) Classification. Class II (special device inputs and outputs. controls). The special controls for this (v) A detailed description of device are: compatible imaging hardware and (1) Design verification and validation imaging protocols. must include: (vi) Warnings, precautions, and (i) A detailed description of the image limitations, including situations in analysis algorithms including, but not which the device may fail or may not limited to, a detailed description of the operate at its expected performance algorithm inputs and outputs, each level (e.g., poor image quality or for major component or block, and certain subpopulations), as applicable. algorithm limitations. 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. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\22JAR1.SGM 22JAR1 Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations (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. 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: khammond on DSKJM1Z7X2PROD with RULES SUMMARY: I. Background Upon request, FDA has classified the radiological computer aided triage and notification software as class II (special VerDate Sep<11>2014 15:46 Jan 21, 2020 Jkt 250001 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 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 3543 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 1 FDA notes that the ‘‘ACTION’’ caption for this final order is styled as ‘‘Final amendment; final E:\FR\FM\22JAR1.SGM Continued 22JAR1

Agencies

[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Rules and Regulations]
[Pages 3540-3543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00497]


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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, 
[email protected].

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

[[Page 3541]]

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.\1\ We 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.
---------------------------------------------------------------------------

    \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) 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.
---------------------------------------------------------------------------

    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 CADx Software for Lesions Suspicious for Cancer
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Incorrect lesion(s) characterization     Certain design verification and
 leading to false positive results may    validation activities
 result in incorrect patient management   identified in special control
 with possible adverse effects such as    (1) and Certain labeling
 unnecessary treatment, unnecessary       information identified in
 additional medical imaging and/or        special control (2).
 unnecessary additional diagnostic
 workup such as biopsy.
Incorrect lesion(s) characterization     Certain design verification and
 leading to false negative results may    validation activities
 lead to complications, including         identified in special control
 incorrect diagnosis and delay in         (1) and Certain labeling
 disease management.                      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).
 diagnostic information being displayed
 to the user.

[[Page 3542]]

 
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).
------------------------------------------------------------------------

    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

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.  892.2060 to subpart B to read as follows:


Sec.  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.

[[Page 3543]]

    (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