DPA Recommends Whole Slide Imaging Manufacturers Submit De Novo Applications to the FDA for Primary Diagnosis in the United States

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Collaboration with FDA Results in Opportunity for Streamlined Approval Process

The Digital Pathology Association (DPA) announced today that it suggests digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA). WSI is a technology which allows glass slides to be reviewed digitally, rather than by a microscope, offering many potential advantages over conventional methodologies. Digital pathology devices are currently not approved for primary diagnostic use in the United States. Until now, the DPA has suggested that manufacturers of WSI devices intended for primary diagnosis plan to submit premarket applications (PMAs). PMAs are required to be approved by the FDA prior to marketing a Class III medical device. Class III is the highest risk classification for medical devices; Class II devices are considered moderate risk and Class I are low risk.

The FDA had previously stated it considered WSI for primary diagnosis to be a Class III medical device. However, FDA had never formally classified these devices. Under certain circumstances manufacturers can opt to submit a de novo application for 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, generally as a Class II device. The DPA is now comfortable suggesting that a manufacturer submit a de novo application based on discussions with the FDA, in which the FDA indicated the WSI for primary diagnosis is a candidate for de novo applications as a Class II device. Once a de novo application receives marketing authorization, other companies will then be able to submit 510(k)s for WSI.

The DPA regulatory task force has had extensive discussions with the FDA under the pre-submission process since mid-2014. The taskforce consists of regulatory experts from the member companies of the DPA, as well as two distinguished pathologists, Drs. Eric Glassy and Anil Parwani. The DPA also contracted with Mr. Jeffrey Gibbs, an expert attorney in FDA law from the law firm of Hyman, Phelps & McNamara, to advise the taskforce. “The possibility that WSI for primary diagnosis could become a Class II device is a significant step forward for the industry,” said Michael Montalto, PhD, Sr. Vice President of Clinical and Medical Affairs for Omnyx. Montalto, who has chaired the DPA regulatory taskforce since 2013, added, “The FDA has been very open and responsive and has given the DPA clear guidance on classification and associated special controls.”

“It is important to realize that WSI for primary diagnosis is still deemed a Class III device,” said Mr. Gibbs. “Only after a first application receives marketing authorization by the FDA would it become a Class II device. The FDA still reserves the right to keep the devices as Class III until an application demonstrates reasonable assurances of safety and effectiveness in combination with general and special controls,” Gibbs said.

In order for a new type of medical device to be considered a suitable candidate for a de novo application, a device manufacturer must establish that the device meets specific criteria, including an appropriate benefit-risk profile. The risks of the device must be well understood and mitigations need to be developed, including special controls, to give reasonable assurances of device safety and effectiveness. In early 2015, the DPA regulatory taskforce submitted documents explaining its position that Class II status was appropriate for WSI intended for use in primary diagnosis. DPA subsequently has met with the FDA to discuss Class II status and has submitted a proposal for special controls for FDA consideration. The DPA and FDA held several meetings over the course of 2015, culminating in a statement by the FDA at the most recent meeting that WSI is a candidate for de novo application.

Dr. Eric Glassy, a pathologist and incoming president of the DPA, served on the taskforce. Glassy said, “The open and collaborative dialogue among pathologists, manufacturers and the FDA has been remarkable and unprecedented. Industry and pathologists have spoken with one voice and the FDA has responded with a framework that will benefit our specialty and, more importantly, our patients”.

The DPA and FDA plan to continue to discuss special controls and other relevant matters related to de novo applications in forthcoming meetings.

About the Digital Pathology Association
The Digital Pathology Association (DPA) is a not-for-profit organization comprised of pathologists, scientists, technologists and representatives from the digital pathology industry. Founded in 2009, the association’s mission is to facilitate “education and awareness of digital pathology in health care.” It’s Board of Directors is composed of a mix of all segments within the digital pathology space, with both US and international representatives. Specifically, users of the technology such as pathologists, histotechnologists and health information technology leaders, as well as industry members from the U.S. and abroad. Members are encouraged to share best practices and promote the use of technology amongst colleagues in order to demonstrate efficiencies, awareness and its ultimate benefits to patient care.

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Michael F. Ward, CAE
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Digital Pathology Association
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