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

News | Breast Imaging | September 20, 2021
September 20, 2021 — ImageCare Centers is unveiling its new “PINK Better Mammo” service with the addition of...
This is an example of 3-D ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

This is an example of TriVu ultrasound imaging on a breast, designed to help increase efficiency and diagnostic accuracy in any practice. Image courtesy of Hologic.

Feature | Breast Imaging | September 15, 2021 | By Jennifer Meade
The...
While the Mammography Quality Standards Act (MQSA) and the introduction of EQUIP (Enhancing Quality Using the Inspection Program) have been successful in standardizing and enhancing mammographic imaging quality, inadequate breast positioning can dramatically impact the ability of radiologists and technicians to quickly and accurately detect breast cancer and potentially malignant lesions in their patients

Getty Images

Feature | Mammography | September 15, 2021 | By Christopher Austin, M.D. and Randy D. Hicks, M.D., MBA
To get more flexibility and cost savings from storage, healthcare organizations are increasing their investments in the cloud
Feature | Information Technology | September 15, 2021 | By Kumar Goswami
Healthcare organizations today are storing petabytes of medical imaging data — lab slides,...
Revenues for teleradiology reading service providers are forecast to follow a similar profile over this period.

Outlook for 2021 and Beyond. As displayed in the figure below, these six market drivers are projected to result in teleradiology reading service volumes increasing by 21% in 2021 and nearly doubling by 2025. Revenues for teleradiology reading service providers are forecast to follow a similar profile over this period.

Feature | Teleradiology | September 15, 2021 | By Arun Gill
The closely tied relationship between...
Cloud services have been utilized within healthcare organizations for more than a decade. Now with the growth of artificial intelligence (AI) it is very common to see organizations adopting cloud services.

Getty Images

Feature | Information Technology | September 14, 2021 | By Jef Williams
As with all imaging technologies, COVID-19 is expected to continue to negatively impact the market.

Courtesy of Grand View Research

Feature | Magnetic Resonance Imaging (MRI) | September 14, 2021 | By Melinda Taschetta-Millane
Figure 1: MWT Schematic of a typical setup for detecting malignant tissues/tumors.

Figure 1: MWT Schematic of a typical setup for detecting malignant tissues/tumors.

Feature | Radiology Imaging | September 14, 2021 | By Brendon McHugh
Us2.ai, a Singapore-based medtech firm backed by Sequoia India and EDBI, has received U.S. Food and Drug Administration (FDA) clearance for Us2.v1, a completely automated AI decision support tool for cardiac ultrasound.
News | Cardiovascular Ultrasound | September 14, 2021
September 14, 2021 – Us2.ai, a Singapore-based medtech firm backed by Sequoia India and EDBI, has received U.S.