The Digital Pathology Association (DPA) is pleased to announce that on November 21, 2018, our Regulatory and Standards Task Force submitted comments to the US FDA draft guidance “Special 510(k) Program”.


Per FDA, the draft guidance aims to improve the Special 510(k) program for devices by clarifying the existing framework and expanding the types of changes that are eligible, with the ultimate goal of increasing the efficiency of 510(k) reviews. This is aligned with recent comments from FDA Commissioner Scott Gottlieb regarding the future of the 510(k) program, “We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”[1]


Due to the current lack of clarity about appropriate situations for submission of a Special 510(k), the program has been historically underutilized. Under the current Special 510(k) program, sponsors routinely have their applications converted to Traditional 510(k)s when device modifications include changes to indications for use and/or changes to the device’s fundamental scientific technology. The draft guidance, when final, intends to expand the Special 510(k) program to include design and/or labeling changes to existing devices under the following circumstances:


  • Changes to the existing device are made by the manufacturer authorized to market the device
  • Performance data are unnecessary to demonstrate substantial equivalence (SE); or, in cases where performance data are necessary to demonstrate SE, well-established methods exist to evaluate the changes
  • When performance data are required to demonstrate SE, they are able to be reviewed in a summary or risk analysis format


Overall, the DPA applauds and appreciates the FDA’s decision to draft a guidance to facilitate the Special 510(k) program. This is an important program that has the potential to allow innovative products to get to market faster without compromising safety. However, there is significant subjectivity in the draft guidance and it remains unclear exactly what changes are appropriate for a Special 510(k), as well as what exactly the criteria are for conversion of a Special 510(k) into a 510(k). It is the overall recommendation of the DPA that FDA add explicit, objective criteria related to when a Special 510(k) can be submitted vs. a Traditional 510(k), in addition to the following more specific requests:


  1. Implement an accelerated Q submission program so sponsors can align with FDA regarding whether device changes require Traditional 510(k) or Special 510(k),
  2. Create a searchable database of cleared Special 510(k)s for vendors to use for reference and consideration, and
  3. Include a decision flowchart to make the Guidance more objective.


The comments submitted to FDA on this draft guidance represent the collective feedback of the pathologists, scientists, technologists, subject matter experts and industry representatives comprising the DPA Regulatory and Standards Task Force. Through the structure offered by the DPA, this Task Force is able to bring all of these important perspectives together to speak with one voice about the unique challenges digital pathology presents to the traditional regulatory framework for devices. We hope that comments from DPA will help to drive FDA to improve upon the foundation of this draft guidance and provide additional, clear direction to industry regarding appropriate use of the Special 510(k) program. The Regulatory and Standards Task Force looks forward to continuing to work together with FDA to help define a practical and predictable regulatory pathway that will contribute to more widespread adoption of digital pathology technologies.




For more information on the DPA Regulatory & Standards Task Force as well as a complete list of members, please click here.