The FDA has proposed reclassifying what it calls radiological medical image analyzers from class III to class II devices. The list includes CAD products for mammography for breast cancer, ultrasound for breast lesions, radiographic imaging for lung nodules, and radiograph dental caries detection devices.
"This [action] will reduce the regulatory burden on the medical device industry, streamline review for these types of computer-assisted detection devices, and provide more timely access to these devices for patients ... [and] will provide a reasonable assurance of safety and effectiveness," the FDA said in a statement.
The FDA regulates medical devices based on their risk to patients and their intended use, using three classifications:
- Class I for low-risk devices, such as medical gloves
- Class II for more complex devices, such as CT and MRI scanners and other radiology systems
- Class III for the highest-risk products, such as stents
In issuing its latest proposal, the FDA stated that all class III medical image analysis products should be reclassified into class II "on the basis that special controls, in addition to general controls, can be established to provide reasonable assurance of the safety and effectiveness of the device."
The agency also noted that the "risk of false-positive results and false-negative results can be mitigated by demonstrating, through clinical performance assessment (e.g., reader studies), that reader performance improves when using the medical image analyzer."
Full details are scheduled for publication in the June 4 issue of the Federal Register, followed by a 60-day comment period.
The new announcement follows a number of steps taken by the FDA over the past year to reclassify computer-related technologies. In July 2017, the agency began to classify breast imaging computer-aided diagnosis (CADx) with artificial intelligence (AI) technology as a class II device, establishing a new generic product type. With that change, vendors now can directly apply for 510(k) clearance rather than navigating the more rigorous premarket approval (PMA) process for class III devices.
The 21st Century Cures Act also prompted the FDA to remove certain software functions from the definition of a medical device, exempting those applications from FDA regulation. In response, the agency late last year released new draft guidance documents for medical software and clinical decision-support (CDS) software.
The FDA last December also drafted a set of guidelines designed to improve the regulatory path for bringing new products to market while maintaining safety requirements. "The Least Burdensome Provisions: Concept and Principles" is designed to eliminate unnecessary burdens that might delay the approval of beneficial products and provide a more consistent application of the agency's principles for medical devices.
Most recently, the FDA in April proposed a new route for vendors to receive 510(k) clearance for certain moderate-risk devices. The draft guidance outlined a voluntary option that allows vendors to demonstrate substantial equivalence of certain new products to legally marketed device types by meeting performance criteria from "well-understood device types."
The FDA is also developing new regulatory framework designed to encourage the use of AI in healthcare. With input from artificial intelligence developers, the agency wants to keep pace with new technology, as it anticipates an increasing number of AI-based submissions in the coming years.
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