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

 

As the eeDAP studies project group continues to develop plans to generate evidence of the value of eeDAP (faster and more precise feature studies comparing WSI to the microscope) for the MDDT submission, the group wanted to evaluate the technical performance of eeDAP. One colleague asked if eeDAP could be qualified as an MDDT with only the technical performance data and no reader studies. Below is the exchange with the FDA MDDT program staff. FDA staff explain the delay in their response to our proposal (response expected before Pathology Informatics), and they provide some limited response to our question about supporting evidence.

 

From: Krainak, Daniel
Sent: Monday, May 01, 2017 8:58 AM
To: Gallas, Brandon D.
Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; MDDT; Anderson, Nicholas
Subject: RE: MDDT031 Proposal - Status inquiry

 

Hello Brandon and the WSI Working Group eeDAP-MDDT project members,

 

 

Thank you for the status inquiry about the eeDAP-MDDT proposal.

 

>> Can you please let us know what is going on?

 

The MDDT program and CDRH leadership placed the proposal on hold so that the MDDT program could resolve some potential programmatic concerns with MDDTs submitted by FDA employees or with significant involvement in MDDT development. We believe that these programmatic challenges have been sufficiently resolved to proceed with review of the proposal.

 

>> When can we expect a response?

 

We hope to make a decision about the proposal within two weeks.

 

>> 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).

 

>> Can this MDDT be approved with only technical performance data?

 

>> Can this MDDT be approved with only technical performance data if we were to change the context of use?

 

>> 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?

 

The Context of Use (COU) for eeDAP proposed in your MDDT proposal cover letter is:

 

eeDAP is a Clinical Outcome Assessment used in reader studies for whole slide imaging premarket submissions (PMA or 510k deNovo) to compare the accuracy or reproducibility of pathologist evaluations of digital images on a display to those of glass slides on a microscope. The pathologist evaluations of patient tissue are the clinical outcomes. The accuracy or reproducibility of the pathologist evaluations is the clinical outcome assessment; this assessment reflects image quality.

 

It is premature to engage in a substantive discussion about the necessary strength of evidence to qualify the context of use (COU), especially if the COU may be modified. However, we would like to clarify that the eeDAP MDDT does not fit well into the MDDT category of clinical outcome assessment or biomarker test or non-clinical assessment model (a non-clinical test model or method that measures or predicts device function or in vivo device performance). The MDDT as described in the proposal appears to be a tool that would facilitate comparisons of pathologist evaluations of digital images on a display to those of glass slides on a microscope.

 

Based on our current thinking, pathologist evaluations of patient tissue are biomarkers. However, our understanding is that the eeDAP MDDT proposed is not a biomarker test, but rather a tool that facilitates consistency in biomarker evaluation. For the purpose of evaluating this MDDT, we believe that the COU, tool and evidence can be well-described even if the type of MDDT is not well-defined. The review of the MDDT can proceed without determining the type.

 

 

We are open to discussing the COU and the associated evidence as discussions about the MDDT proceed. The criteria for qualification do not necessitate clinical data, the evidence will primarily depend upon the MDDT and the context of use. The decision framework for qualification is currently:

 

• MDDT description.  Is the MDDT adequately described?
• Context of use.  Is the proposed context of use adequately and appropriately defined?
• Public Health Impact. Would the scope and use of the tool have a broad public health impact?
• Strength of evidence.  Does the available scientific evidence demonstrate that the MDDT reliably and accurately measures what is intended, is scientifically plausible, and is reasonably likely to predict the outcome of interest?
• Assessment of advantages and disadvantages.  Within the specified context of use and given the available strength of evidence, do the advantages outweigh potential disadvantages of making decisions based on measurements obtained using the MDDT?  Of particular importance are regulatory, public health, and/or clinical impact.

 

 

If you have any questions, please feel free to contact me.

 

Regards,

Dan Krainak

 

On behalf of the MDDT pilot program

 

 

Daniel M. Krainak, Ph.D.
Biomedical Engineer              

Center of Devices and Radiological Health
Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration
Tel: 301-796-0478
Daniel.Krainak@fda.hhs.gov

 

 

       

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received.

 

 

 

 

From: Krainak, Daniel
Sent: Wednesday, April 26, 2017 2:17 PM
To: Gallas, Brandon D.
Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; MDDT
Subject: RE: MDDT031 Proposal Acknowledgement Letter

 

Hi Brandon,

 

We received your status inquiry below and should have a more complete status update by the end of this week.

 

Regards,

Dan

 

Dan Krainak
Biomedical Engineer | Division of Radiological Health           

Center of Devices and Radiological Health
Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration
Tel: 301-796-0478
Daniel.Krainak@fda.hhs.gov

 

 

       

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received.

 

 

 

 

From: Gallas, Brandon D.
Sent: Wednesday, April 19, 2017 9:51 AM
To: MDDT
Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel
Subject: RE: MDDT031 Proposal Acknowledgement Letter

 

Good morning everyone.

 

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.

Can you please let us know what is going on?

When can we expect a response?

 

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).

Can this MDDT be approved with only technical performance data?

Can this MDDT be approved with only technical performance data if we were to change the context of use?

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?

 

Thanks,

 

Brandon Gallas and the WSI Working Group eeDAP-MDDT project members

 

 

From: Gallas, Brandon D.
Sent: Wednesday, March 08, 2017 2:51 PM
To: MDDT
Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel
Subject: RE: MDDT031 Proposal Acknowledgement Letter

 

Thanks for the update. I was wondering …

 

Brandon

 

From: MDDT
Sent: Wednesday, March 08, 2017 1:52 PM
To: MDDT; Gallas, Brandon D.
Cc: Lochner, Donna R.; Scharen-Guivel, Hilda; Krainak, Daniel
Subject: RE: MDDT031 Proposal Acknowledgement Letter

 

Good Afternoon Dr. Gallas,

 

MDDT031 is still under consideration.  We will contact you on how to proceed once a decision  has been made.

 

If you have any questions, please feel free to contact  me.

 

v/r

 

 

Joan Adams-White

Regulatory Health Project Manager

Food and Drug Administration

CDRH/OCD/CSC

10903 New Hampshire Ave

WO66, Room 5519

Silver Spring, MD 20993

Off: 301-796-5421

Joannie.adams-white@fda.hhs.gov">Joannie.adams-white@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=100&D=120&B=121&E=&S=E

 

From: MDDT
Sent: Friday, January 27, 2017 3:49 PM
To: Gallas, Brandon D.
Cc: MDDT; Lochner, Donna R.
Subject: MDDT031 Proposal Acknowledgement Letter

 

Good Morning Dr. Gallas,

 

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.

 

Regards,

 

The MDDT Program Staff

MDDT@fda.hhs.gov