Regulatory Focus™ > News Articles > 2020 > 1 > Updated: FDA Classifies Three Radiology Devices Into Class II

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Posted 22 January 2020 | By Michael Mezher 

Updated: FDA Classifies Three Radiology Devices Into Class II

2899 Editor's note: This article has been updated to reflect the release of an updated guidance related to medical image analyzers.

The US Food and Drug Administration (FDA) on Tuesday classified two software-based radiology devices into Class II (special controls) following requests for de novo classification from their sponsors. The agency also reclassified medical image analyzers from Class III to Class II.

FDA also released an updated version of its 2012 guidance, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, to reflect the reclassification of medical image analyzers. FDA notes that recommendations pertaining to the special controls placed on medical image analyzers in the guidance are italicized.
Specifically, FDA issued two final orders codifying the generic device type and special controls applicable to Quantitative Insights’ Quant X and’s ContaCT after classifying the devices into Class II in July 2017 and February 2018, respectively.
The generic device type for Quant X will be referred to as radiological computer-assisted diagnostic software for lesions suspicious for cancer, whereas the generic device type for ContaCT will be referred to as radiological computer aided triage and notification software.
Both orders list a set of special controls that will apply to other devices of the same types that identify risks and mitigation measures necessary to provide reasonable assurance of safety and effectiveness for the devices.
FDA is also reclassifying from Class III to Class II medical image analyzers regulated under product code MYN, which includes computer-assisted/aided detection (CADe) devices for mammography and breast ultrasound as well as radiographic detection of lung nodules and dental caries.
FDA first proposed reclassifying the devices in June 2018, noting at the time that other CADe devices have been regulated as Class II and that “evidence suggests that the safety profiles for existing Class III CADe devices are similar to the Class II CADe.”
FDA is not exempting medical image analyzers from premarket notification (510(k)) requirements as the agency has “determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness for medical image analyzers.”
The final order also spells out the special controls that will apply to medical image analyzers, including four design verification and validation controls as well as eight labeling-related controls.
Federal Register Notices: Radiological Computer Aided Triage and Notification Software, Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer, Medical Image Analyzers


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