Email to FDA MDDT review team 20170419
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- Version 2
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| 1 | From: Gallas, Brandon D. [[BR]] | |||
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| 2 | Sent: Wednesday, April 19, 2017 9:51 AM [[BR]] | |||
| 3 | To: MDDT [[BR]] | |||
| 4 | Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel [[BR]] | |||
| 5 | Subject: RE: MDDT031 Proposal Acknowledgement Letter [[BR]] | |||
| 6 | ||||
| 7 | Good morning everyone. | |||
| 8 | ||||
| 9 | - | The WSI working group members on this eeDAP-MDDT project have had T-cons to plan the studies to support the eeDAP MDDT. We are all anxious to hear back so that we proceed in the right direction. We are falling behind in our plans for developing our protocols and logistics and are feeling pressure because we have committed to providing an update to the larger WSI working group and the public at the Pathology Informatics Summit May 21-25.
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+ | The WSI working group members on this eeDAP-MDDT project have had T-cons to plan the studies to support the eeDAP MDDT. We are all anxious to hear back so that we proceed in the right direction. We are falling behind in our plans for developing our protocols and logistics and are feeling pressure because we have committed to providing an update to the larger WSI working group and the public at the Pathology Informatics Summit May 21-25. [[BR]]
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| 10 | - | Can you please let us know what is going on?
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+ | Can you please let us know what is going on? [[BR]]
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| 11 | When can we expect a response? | |||
| 12 | ||||
| 13 | - | We also have a big question that we would like feedback on. Specifically, we have outlined plans to conduct reader studies to provide evidence to support the context of use (pathologist performance). We have also outlined plans to characterize the accuracy of the image registration process and the color reproduction (technical performance).
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+ | We also have a big question that we would like feedback on. Specifically, we have outlined plans to conduct reader studies to provide evidence to support the context of use (pathologist performance). We have also outlined plans to characterize the accuracy of the image registration process and the color reproduction (technical performance). [[BR]]
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| 14 | - | Can this MDDT be approved with only technical performance data?
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+ | Can this MDDT be approved with only technical performance data? [[BR]]
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| 15 | - | Can this MDDT be approved with only technical performance data if we were to change the context of use?
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+ | Can this MDDT be approved with only technical performance data if we were to change the context of use? [[BR]]
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| 16 | If a new context of use is necessary, can you help us reframe the context of use so that this MDDT can be approved with only technical performance data? | |||
| 17 | ||||
| 18 | Thanks, | |||
| 19 | ||||
| 20 | Brandon Gallas and the WSI Working Group eeDAP-MDDT project members | |||
| 21 | ||||
| 22 | ---- | |||
| 23 | ||||
| 24 | From: Gallas, Brandon D. | |||
| 25 | Sent: Wednesday, March 08, 2017 2:51 PM | |||
| 26 | To: MDDT | |||
| 27 | Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel | |||
| 28 | Subject: RE: MDDT031 Proposal Acknowledgement Letter | |||
| 29 | ||||
| 30 | Thanks for the update. I was wondering … | |||
| 31 | ||||
| 32 | Brandon | |||
| 33 | ||||
| 34 | From: MDDT | |||
| 35 | Sent: Wednesday, March 08, 2017 1:52 PM | |||
| 36 | To: MDDT; Gallas, Brandon D. | |||
| 37 | Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel | |||
| 38 | Subject: RE: MDDT031 Proposal Acknowledgement Letter | |||
| 39 | ||||
| 40 | Good Afternoon Dr. Gallas, | |||
| 41 | ||||
| 42 | MDDT031 is still under consideration. We will contact you on how to proceed once a decision has been made. | |||
| 43 | ||||
| 44 | If you have any questions, please feel free to contact me. | |||
| 45 | ||||
| 46 | v/r | |||
| 47 | ||||
| 48 | ||||
| 49 | Joan Adams-White | |||
| 50 | Regulatory Health Project Manager | |||
| 51 | Food and Drug Administration | |||
| 52 | CDRH/OCD/CSC | |||
| 53 | 10903 New Hampshire Ave | |||
| 54 | WO66, Room 5519 | |||
| 55 | Silver Spring, MD 20993 | |||
| 56 | Off: 301-796-5421 | |||
| 57 | Joannie.adams-white@fda.hhs.gov | |||
| 58 | Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: | |||
| 59 | https://www.research.net/s/cdrhcustomerservice?O=100&D=120&B=121&E=&S=E | |||
| 60 | ||||
| 61 | ---- | |||
| 62 | ||||
| 63 | From: MDDT | |||
| 64 | Sent: Friday, January 27, 2017 3:49 PM | |||
| 65 | To: Gallas, Brandon D. | |||
| 66 | Cc: MDDT; Lochner, Donna R. | |||
| 67 | Subject: MDDT031 Proposal Acknowledgement Letter | |||
| 68 | ||||
| 69 | Good Morning Dr. Gallas, | |||
| 70 | ||||
| 71 | Thank you for your interest in the MDDT Pilot Program. Please see the attached MDDT031 Proposal Acknowledgment of Receipt. We will review your proposal and communicate our determination regarding acceptance into the MDDT Pilot Program within 30 days of receipt. | |||
| 72 | ||||
| 73 | Regards, | |||
| 74 | ||||
| 75 | The MDDT Program Staff | |||
| 76 | MDDT@fda.hhs.gov | |||