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  • Created 01 Aug 2014

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

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
Center For Devices and Regulatory Health
Office of Science and Engineering Laboratories
U.S. Food and Drug Administration

Tel: 301-796-2531

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Comments on this entry

  1. Brandon D. Gallas

    I hand delivered the package a few minutes ago.

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    Replying to Brandon D. Gallas

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