A Move by the FDA Signals Possible Classification for Patient Safety and Industry Collaboration
On Jan. 14, 2016, the Digital Pathology Association (DPA) issued a press release suggesting “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).”
What exactly does this mean?
The press release goes on to say, “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.”
This is excellent news for the digital pathology community. The combined efforts of DPA’s regulatory taskforce, composed of pathologist and industry leaders working in tandem with representatives from the FDA, appear to have reached common ground with plans for next steps forward.
One of the historic challenges with the regulation of WSI has been the lack of a clear classification of these devices. Out of concern for patient safety WSI devices have largely been regarded as Class III devices, requiring full premarket applications (PMAs) before manufacturers could make claims about their use for primary diagnosis in the U.S. Lengthy PMAs are required to be approved by the FDA, prior to marketing a Class III medical device. Class III is the most high-risk classification for medical devices; Class II devices are considered moderate risk, and Class I is reserved for the lowest risk devices.
For many years, I for one, have been confused by the regulatory issue. First and foremost, we have had dozens of quantitative image analysis applications approved under the 510(k) process without first addressing the primary diagnosis H&E issue (to which we are now returning). Without a formal process in place and without a predicate device to measure it against, WSI devices have been classified as Class III – but perhaps with community recognition we could ensure patient safety utilizing self-validation under a Class II level categorization.
This paradigm appears to be changing based on discussions with the FDA that applications may be submitted for WSI for primary diagnosis as a Class II device, rather than requiring the more significantly more extensive PMA required for a Class III device. With approval, other companies will be able to submit 510(k)s for WSI.
The press release goes on to quote a regulatory attorney who makes it clear that until an individual manufacturer travels down the road toward Class II approval, WSI devices will still be deemed Class III devices – and the FDA reserves the right to maintain the Class III classification.
There seems, however, to be positive dialogue between the FDA and DPA. These discussions will ensure that appropriate general and special controls are adhered to that meet the needs of manufacturers and system users (pathologists and technologists), and, most importantly, patient safety, in the use of WSI devices.
This new framework will allow industry, laboratories, pathologists, and government agencies to ensure safe, effective, and timely approvals – following on the heels of many long years of extensive dialogue, and perhaps even after a few PMAs to address primary diagnosis that were not considered suitable submissions.
The news is encouraging. As with other new technologies in the laboratory, the recognition and appreciation for appropriate validation and use of WSI for primary diagnosis means pathologists and patients will ultimately benefit from these shared interests.
A new dawn is upon us for WSI and primary diagnosis.
So, who will be the first to go down the de novo Class II route and open the floodgates for the many 510(k) applications to follow?