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

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 | Prostate Cancer

July 9, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer ...

Time July 09, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning ...

Time July 03, 2025
arrow
News | Ultrasound Imaging

July 1, 2025 — UPDATE: The final paper is now available at: JMIR AI - ChatGPT-4–Driven Liver Ultrasound Radiomics ...

Time July 01, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its ...

Time June 26, 2025
arrow
News | Prostate Cancer

June 26, 2025 – Quibim, a global provider of quantitative medical imaging solutions, has launched AI-QUAL, a new feature ...

Time June 26, 2025
arrow
News | Bone Densitometry Systems

June 19, 2025 — Naitive Technologies has published results demonstrating the diagnostic performance of its AI-powered ...

Time June 18, 2025
arrow
News | Lung Imaging

June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...

Time June 18, 2025
arrow
News | Digital Pathology

June 11, 2025 — Diagnostic laboratory leaders view digital pathology and artificial intelligence (AI) as pivotal to ...

Time June 12, 2025
arrow
News | Lung Imaging

June 11, 2025 — To prepare healthcare workforces and providers for an AI-driven future, Qure.ai has expanded its Global ...

Time June 11, 2025
arrow
News | Radiology Imaging

June 10, 2025 — CIVIE has announced the official launch of RadPod, an AI-driven, on-demand radiology platform designed ...

Time June 10, 2025
arrow
Subscribe Now