On January 15, 2021, the U.S. Department of Health and Human Services (HHS) published a Federal Register notice proposing to exempt 91 medical devices from the requirement for submission of a 510(k) premarket notification. During the COVID-19 pandemic, the 510(k) requirement was temporarily waived for these devices. The notice requested the public to comment and we, the Regulatory and Standards DPA taskforce, took the opportunity to publicly comment, providing more information about available research and analysis related to digital pathology devices.


The HHS’s notice proposed that the 510(k) premarket notification not be required for multiple devices, including several different digital pathology devices. The HHS notice relied heavily on the infrequency of reports of adverse events. (The notice was published around the same time when FDA published their action plan for Artificial Intelligence and Machine Learning[1]. This plan specifically set forth an expanded regulatory framework for machine learning devices.)


DPA commented that we generally agree with the approach to reduce the regulatory burden on medical devices when there is scientific evidence that suggests it is safe to do so. More specifically, we provided information about numerous published studies showing high accuracy for primary diagnoses using whole slide images (WSIs) of glass slides. In addition, during the pandemic the emergency use authorization from CMS as well as FDA allowed use of uncleared digital pathology systems for remote sign out. This has allowed users to combine various cleared as well as uncleared hardware and software devices in evaluating tissue samples. A recent publication[2] showed successful validation of remote use of digital pathology systems, including the use of a variety of displays.


These data, together with the fact that Whole Slide Imaging devices are being used globally with a low incidence of adverse events, led us to advocate for the 510(k)-exempt status of certain WSI devices.  We also recommended the use of a more modularized regulatory approach to enhance interoperability. That is, DPA believes all the individual subsystems should be permitted to operate as independent, platform-agnostic components that interoperate within a WSI system.


We suggested that with proper technical performance assessments that define the necessary evidence that devices as interoperable components can be brought safely to the market.


On April 15, 2021, one month after the public comment period closed on March 15, 2021, the FDA published a notice that it would not adopt the proposal, and that devices covered by the proposed rule will continue to be subject to the premarket notification requirement. According to the administration, the determination to withdraw was based on review of the notice, its comments, inquiries to FDA, and other relevant information.  It was determined that the proposed exemptions and bases for them were flawed.


Although the HHS proposal has been withdrawn, DPA still believes that a more modularized approach to digital pathology systems is feasible and will help spur adoption of this technology. Therefore, we will keep collaborating with the FDA to facilitate the adoption of a modular approach.


On behalf of the DPA Regulatory and Standards Taskforce,

Esther Abels


[1] Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan, January 2021

[2] Hanna MG, Reuter VE, Ardon O, et al. Validation of a digital pathology system including remote review during the COVID-19 pandemic. Mod Pathol. 2020;1-13