News | Computer-Aided Detection Software | January 22, 2020

FDA Reclassifies Medical Image Analyzers, Including CADe Devices

The final order reclassifies certain CADe devices from Class III to Class II devices, subject to premarket 510(k) notification

he U.S. Food and Drug Administration (FDA) has issued a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification

Image courtesy of iCAD

January 22, 2020 — The U.S. Food and Drug Administration (FDA) has issued a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type. The order will be effective Feb. 21, 2020. 

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3). Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use.

On June 4, 2018 (83 FR 25598), FDA published in the Federal Register a proposed order to reclassify the device type from class III to class II, subject to premarket notification. The comment period on the proposed order closed on August 3, 2018.

You can read the full published final order here

Related Content

Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for its head CT scan product qER. The US Food and Drug Administration's decision covers four critical abnormalities identified by Qure.ai's emergency room product.
News | Artificial Intelligence | June 30, 2020
June 30, 2020 — Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for
Sponsored Content | Videos | PACS | June 29, 2020
Kevin Borden, Vice President of Product, Healthcare IT for Konica Minolta, talks about Improving Access and Aiding Wo
Universal digital operating system for surgery enables health tech companies and start-ups to accelerate, scale and grow

Stefan Vilsmeier, President and CEO of Brainlab Photo courtesy of Brainlab

News | Artificial Intelligence | June 26, 2020
June 26, 2020 — ...
n support of Mayo Clinic’s digital health and practice transformation initiatives, the Mayo Clinic Department of Laboratory Medicine and Pathology has initiated an enterprise-wide digital pathology implementation of the Sectra digital slide review and image storage and management system to enable digital pathology. 
News | Enterprise Imaging | June 26, 2020
June 26, 2020 —  In support of Mayo Clinic’s digital health
Visage announces cloud implementation, Visage 7 Workflow and semantic annotations
News | Enterprise Imaging | June 26, 2020
June 26, 2020 — Visage Imaging, Inc.
The American College of Radiology (ACR) Center for Research and Innovation (CRI) is pleased to announce the development of the COVID-19 Imaging Research Registry (CIRR), an effort by the ACR CRI and the ACR Data Science Institute in collaboration with the ACR and the Society of Thoracic Radiology (STR). Sharyn Katz, M.D., director of research for thoracic radiology at the University of Pennsylvania, chairs the effort’s multiple-disciplinary steering committee, which includes representation from across the i

Getty Images

News | Coronavirus (COVID-19) | June 25, 2020
June 25, 2020 — The American College of Radiology (ACR) Center for R