Last week news was released after months of speculation, that the FDA would consider the de novo classification option for digital pathology systems as a pathway for bringing to market a moderate or low risk device which has not yet been classified, and for which there is no predicate device (as in whole slide imaging systems). If the FDA authorizes the marketing of a device based on a de novo application, the device will at that point become classified, in most cases as a lower-risk Class II device, subject to FDA 510(k) requirements.
This of course is significant news for industry, laboratories and pathologists. After years of confusion regarding classification without a sound classification and important questions about appropriate use and patient safety without a predicate device to measure against, this approach seems mutually beneficial for manufacturers and consumers in the best interests of patient safety to bring these technologies to market for primary diagnosis.
The Digital Pathology Association (DPA) regulatory taskforce chaired by Dr. Mike Montalto mentioned here last week has been working with the FDA towards an approval process that will insure patient safety while allowing manufacturers a pathway short of a full pre-market application (PMA).
The horizon for whole slide imaging for primary diagnosis is bright for patients and pathologists!
Digital Technology for Cancer Diagnosis in the US is on the Horizon
Patients in the U.S. are now one step closer to having access to cancer diagnoses powered by the latest digital technology. This technology has the potential to help doctors deliver results more quickly and more precisely than the status quo. Currently, pathologists render their diagnoses using slides and microscopes in much the same way that they have for the past 100 years. Digital pathology systems have been developed that allow pathologists to analyze and evaluate slide images on a computer, performing functions not possible using traditional slides and microscopes, which offers many potential advantages.
“Patients deserve the peace of mind that comes with knowing their doctors have made their diagnosis by utilizing all of the information available to them,” said Mamar Gelaye, CEO of Omnyx. “And, because cancer waits for no one, we have to act with a sense of urgency. Lives can depend on it.”
As a key member of the Digital Pathology Association (DPA) regulatory taskforce, Omnyx has worked collaboratively for the last several years with other manufacturers, pathologists, and the Food and Drug Administration (FDA) to review the current process for bringing this innovative technology to U.S. clinicians, which will ultimately benefit patients. In recent discussions, the FDA has indicated willingness to consider a less burdensome approval approach for digital whole slide imaging (WSI), without impacting safety or effectiveness.
“Digital pathology is a transformative technology that enables significant improvements in workflow and collaboration,” said George Michalopoulos, M.D., PhD, Chairman of the Department of Pathology at UPMC. “Moreover, transitioning from glass to digital enables the development of next generation software tools, such as advanced image analysis and algorithms, as well as integration with molecular and genomic testing that can lead to more precise and individualized treatment plans.”
The DPA recently issued a press release recommending that manufacturers of WSI devices submit de novo applications to the FDA for primary diagnosis in the US. Once one de novo application receives marketing authorization from the FDA, other companies will then be able to submit 510(k) applications for their WSI devices rather than submit and maintain the more lengthy and complex Premarket Approval (PMA) application.
Historically the FDA has taken the position that since there are no equivalent FDA-cleared (i.e. predicate) devices, WSI devices used for primary diagnosis are high-risk, Class III medical devices. In order to legally sell a Class III device in the U.S. for use in primary diagnosis, manufacturers must obtain approval from the FDA by submitting through the lengthy and expensive PMA application process.
In 1997, the de novo classification option was established by law as an alternate pathway for bringing to market a moderate or low risk device which has not yet been classified, and for which there is no predicate device. If the FDA authorizes the marketing of a device based on a de novo application, the device will at that point become classified, in most cases as a lower-risk Class II device, subject to FDA 510(k) requirements.
“Omnyx applauds the DPA for its tireless efforts and acknowledges the FDA’s willingness to constructively engage with members of the digital pathology community on this important matter,” said Larry Kopyta Senior Vice President, Quality & Regulatory Affairs at Omnyx. “The de novo approach for WSI devices, when successful, will help bring this technology to patients more quickly, and spur additional innovation within the industry.”
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