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Articles are contributed by DPA members & non-members - and do not necessarily express the viewpoints of the DPA.
Posted on 12/11/2018 by Jennifer Tucker
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pleased to announce that on November 21, 2018, our Regulatory and Standards Task Force submitted comments to the US FDA draft guidance “Special 510(k) Program”.
Per FDA, the draft guidance aims to improve the Special 510(k) program for devices by clarifying the existing framework and expanding the types of changes that are eligible, with the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 The draft guidance, when final, intends to expand the Special 510(k) program to include design and/or labeling changes to existing devices under the following circumstances:
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 However, there is significant subjectivity in the draft guidance and it remains unclear exactly what changes are appropriate for a Special 510(k), as well as what exactly the criteria are for conversion of a Special 510(k)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:
The comments submitted to FDA on this draft guidance represent the collective feedback of the pathologists, scientists, technologists, subject matter experts and industry representatives comprising the DPA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.
[1] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm
For more information on the DPA Regulatory & Standards Task Force as well as a complete list of members, please click here.
2 comment(s) on "Task Force Comments on FDA Draft Guidance “Special 510(k) Program”"
12/11/2018 at 07:00 PM
Prakash chaudhari says:
I have started making Digital path DX on Phillips remotely.I am interested working for the groups interested working with me fo AI or consultation.
Do we have a forum I can join as Expert in Dermatopathology??
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02/11/2019 at 07:00 PM
Neha says:
Amazing article,Thanks for sharing update related to FDA’s 510k Draft Guidance. Thanks for sharing…
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