• Discoverability Visible
  • Join Policy Restricted
  • 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

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


Comments on this entry

  1. Brandon D. Gallas

    I hand delivered the package a few minutes ago.

    Step 1 complete.

    Reply Report abuse

    Replying to Brandon D. Gallas

  2. Anonymous

    Cancer is the chronic disease in the past there was no treatment against this disease but now you can buy essays for useful task. But now in this modern world different communities and centers are working for its treatment that is truly great. I appreciate them for this great work.

    Reply Report abuse

    Replying to Anonymous

  3. Mia Jack

    Such a informative blog for the doctor those they are doing as well as who has complete. They should read because it may help out for order an Assignment | AssignmentClock the new technique along with it can improve your knowledge about the digital equipment.

    Reply Report abuse

    Replying to Mia Jack

Post a comment

You must log in to post comments.

Please keep comments relevant to this entry.

Line breaks and paragraphs are automatically converted. URLs (starting with http://) or email addresses will automatically be linked.