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Time to submit proposal: FDA/CDRH Medical Device Development Tool for digital pathology

Entry #222
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This announcement is an update of our efforts to qualify eeDAP as a Medical Device Development Tool. If you are unfamiliar with this project, eeDAP, or the Medical Device Development Tool program, please refer to earlier blog items:
21 October 2017: FDA/CDRH Medical Device Development Tool
09 January 2017: Draft Proposal of FDA/CDRH Medical Device Development Tool

I have received comments from a couple WSI WG members and from FDA/CDRH staff, and I have updated the proposal accordingly.
Updated Proposal: MDDTproposal-2.pdf
Review Comments

I will submit this proposal COB Wednesday, giving a day for you to review. If you have comments, send them directly to me.

Next steps: I have contacted several groups that have expressed interest in running an eeDAP study at their institution, and I am having one-off meetings with them to discuss their goals and plans. Once we finish with basic introductions, we will start planning 1-3 eeDAP studies together. If you are interested in joining this team, contact me.

 

Thank you,

Brandon D. Gallas
Mathematician     
Center For Devices and Regulatory Health
Office of Science and Engineering Laboratories
U.S. Food and Drug Administration
Tel: 301-796-2531
Brandon.Gallas@fda.hhs.gov

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?O=700&D=770&B=770&E=&S=E

 

About the author

Brandon D. Gallas

Brandon D. Gallas provides mathematical, statistical, and modeling expertise to the evaluation of medical imaging devices at the FDA. His main areas of research are image quality, computer-aided diagnosis, imaging physics, and the design, execution, and statistical analysis of reader studies (https://github.com/DIDSR/iMRMC/releases , https://cran.r-project.org/web/packages/iMRMC/index.html ). Recently, he has been investigating pathologist performance and agreement using whole slide imaging devices and the microscope (https://ncihub.org/groups/eedapstudies ). These studies are enabled by an evaluation environment that registers the digital images to the glass slides (https://github.com/DIDSR/eeDAP/releases ). Dr. Gallas also participates in the Pathology Innovation Collaborative Community (https://www.pathologyinnovationcc.org/ ), a regulatory science initiative to harmonize and standardize digital pathology processes to speed up innovation to patients.

Comments on this entry

  1. Brandon D. Gallas

    I hand delivered the package a few minutes ago.

    Step 1 complete.

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    Replying to Brandon D. Gallas

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We’re already opening to see the impending impact of digital pathology on identification and progressive reform. Some of our systems can realize patterns of malady related to prognosis or medical care reply that isn't available by different means that, which might afford additional...

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