FDA Intends to Reclassify Digital Pathology Systems

BY Richard Morroney. March 3, 2016

The digital pathology industry got a shot of adrenaline with the recent announcement by the Digital Pathology Association (DPA) that the Food and Drug Administration (FDA) is willing to reclassify digital pathology Whole Slide Imaging (WSI) systems used for primary diagnosis of cancer. These systems are currently regulated as high-risk (Class III) devices. As a result of the collaborative effort between the DPA’s regulatory task force and the FDA, the FDA has agreed to review the digital pathology system market clearance applications via a less burdensome regulatory pathway. This will ultimately lead to reclassification of digital pathology for primary diagnosis from the high-risk Class III category to the medium risk Class II category.

Digital pathology devices used for primary diagnosis will transform the 100-year-old workflow process by creating a digital information workflow enabled by computer technology. Process improvements through automation mean that pathologists will be able to work faster and smarter with less chance for error. And, manufacturers will be able to get their devices into the hands of pathologists sooner resulting in potentially better outcomes for patients.

De Novo Process

Currently, the FDA regulates WSI devices used for digital manual reads as Class II. These devices allow digitized images of IHC-stained breast tissue for the detection of HER-2 protein to be used by pathologists only after primary diagnosis has been made using the glass slides and a microscope. Under the Food, Drug, and Cosmetic Act, WSI devices used for primary diagnosis are automatically classified as high-risk Class III devices because intended use is new and, therefore, there is no Class II predicate.

Obviously, not all new devices present a high risk/benefit profile warranting automatic high-risk classification and the associated burdensome pathway to commercialization. For this reason in 1997, as part of the Food and Drug Modernization Act (FDAMA), the FDA established the de novo pathway as a regulatory mechanism to achieve the least burdensome approach to market for new devices that may not necessarily warrant the high-risk classification.

Under FDAMA, the de novo classification process provides a pathway to Class I or Class II classification for medical devices for which there is no legally marketed predicate, but for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness. This pathway enables device manufacturers and the FDA to avoid the costly development associated with Class III devices and the lengthy resource-intensive approval processes respectively.

The FDA and the DPA task force together have identified key areas of safety and efficacy associated with digital pathology technology along with mitigating factors, which are called “special controls” to ensure the safety and effectiveness of WSI systems.

The special controls for digital pathology systems enable manufacturers to define and provide adequate data in the de novo application that will provide reasonable assurance of safety and effectiveness. These special controls include selected data sets used for testing, technical performance studies, analytic studies, clinical studies to establish intra- and inter-reader variable performance, human factors studies, clinician training, labeling, post-market surveillance, and a schema for ensuring continued safety and effectiveness to manage product design changes.

If the data and information included in the de novo application demonstrates that the special controls are adequate to provide a reasonable assurance of safety and effectiveness, the FDA will grant the de novo and classify the device as either Class I or Class II. Thereafter, subsequent marketing applications will be subject to the less burdensome pathway to commercialization, which is the 510(k) premarket notification process.

Effects of Reclassification

The effects of reclassification will be a boon to the healthcare industry. A less burdensome pathway will draw more manufacturers into the digital pathology field increasing competition and resulting in more innovation. Scanner technology will evolve resulting in higher quality image data. There will be a proliferation of next-generation software tools to process and analyze myriad data that will be available.

Pathologists will be able to work smarter and faster thanks to the many benefits of unifying the pathology workflow to an all-digital format. It will significantly improve the 100-year-old environment that requires pathologists to operate in both the analog space (where they handle glass slides and interpret what’s on them with a microscope) and the digital space (where they access patient data contained in PACS systems and electronic health records). The added benefits of data integration alone will translate to less time being spent by pathologists assembling cases. In turn, the less time spent reconciling the analog information with the digital information, means more time focused on interpreting cases.

Next-generation software algorithms and diagnostic support systems that perform computational image analysis will visually assist pathologists in identifying critical diagnostic information. Pathologists can work faster using image analysis tools such as algorithms that can detect abnormal and potentially cancerous cell morphologies. These informed detection tools will organize cases and slides, putting the most difficult cases first in the pathologist’s case list and identifying specific slides with areas of interest highlighted. Pathologists will be able to decrease overall case turn-around-time by focusing on the most difficult cases first and focusing on the areas of slides that have been prescreened as having suspicious cells present.

In the war against cancer, speed and accuracy are critical factors. The benefits of automation will arm pathologists with tools that will not only speed up their workflow but will also enable them to make better informed decisions based on rapid access to comprehensive patient information and image sharing for collaboration and second opinions.

For patients, faster and more accurate diagnosis can mean the difference between life and death. Patients can have peace of mind knowing that there is less chance for error with digital pathology technology assisting pathologists.

Inspirata applauds both the FDA and the DPA for their efforts to bring this promising technology to market faster thus ultimately facilitating more rapid and improved treatment decisions for better patient care.

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Richard Morroney

Richard Morroney, RAC, CQA, is responsible for ensuring global regulatory compliance for Inspirata’s solution offerings. He has more than 20 years of experience in manufacturing operations, internat... Learn More