FDA/CDRH Medical Device Development Tool
Hello all,
It has been a quiet summer for the WSI WG. We tried to get space at Pathology Visions, but we were unsuccessful. So what next?
My management has asked that I submit the tool eeDAP to the FDA/CDRH MDDT program (Medical Device Development Tool).
eeDAP stands for evaluation environment for digital and analog pathology, and I discussed it during my talk at Pathology Informatics last May. Below are links to the presentation slides (eeDAP is discussed from slide 23-29) and a paper we wrote describing it. eeDAP has been updated since the paper to work with other cameras, stages, and proprietary file formats.
- Presentation: https://nciphub.org/projects/wsiwgproject/files/download?subdir=20160522%20PathologyInformatics/presentationProposals/BrandonGallas-FDA&asset=WSIWGatPathInfo_MitoticCountReproducibilityStudy-4.pptx
- Paper: http://www.ncbi.nlm.nih.gov/pubmed/26158076
- Software: https://github.com/DIDSR/eeDAP/releases
What is an MDDT?
Here is a link to a presentation summarizing the program: http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM358867.pdf
Here is FDA/CDRH draft guidance on the MDDT program: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm374427.htm
“An MDDT is a scientifically validated tool - a clinical outcome assessment (e.g. patient-reported or clinician-reported rating scales), a test used to detect or measure a biomarker (e.g. assay for a chemical analyte or medical imaging method), or non-clinical assessment method or model (e.g. in vitro, animal or computational model) - that aids device development and regulatory evaluation. Qualification reflects CDRH’s expectation that within a specified context of use1, the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making.”
The MDDT submission and qualification process are not drastically different from a medical device submission, except the purpose of the MDDT is to *support* regulatory decision-making (an MDDT is not a medical device). An MDDT gets reviewed by FDA/CDRH pretty much like a medical device would get reviewed.
“Once an MDDT is qualified for a specific context of use, FDA’s expectation is that it can be used by any medical device developer for that context of use. CDRH reviewers should accept the MDDT for the qualified context of use without the need to reconfirm the suitability of the MDDT.”
For the benefit of the WSI WG community (and beyond), I am willing to document the process of qualifying eeDAP as an MDDT on our group page, share submission materials and feedback, and involve other groups and individuals on the submission. I and my colleague Marios Gavrielides are also willing to support another group or individual in the qualification of another MDDT. For example, we could identify a context of use for the micro beads or for another calibration slide.
If you have any questions, would like to be involved, or have ideas for your own MDDT, email me personally or comment at the blog. Progress updates will follow.
Brandon D. Gallas, PhD
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
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About the author
anant agrawal @ on
Great idea to submit to the MDDT program.
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Esther Abels @ on
Hi Brandon
I fully support your idea to get the eeDAP registered as an MDDT and would like the WSI WG to advance this with you. In addition, I also support your thoughts of having the phantom beads developed further and get this registered as an MDDT too.
I have been sharing your idea with a few others and there is interest. I suggest to present how your tool and eventually a phantom can be beneficial for the DP community, such as for Medical Device submissions and/or pathologists / researchers during a webinar.
Shall we set something up?
Best regards,
Esther Abels
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Brandon D. Gallas @ on
Thanks for your support Anant and Esther. I hope to have a draft submission (full or partial) that I will share with the group. I will try and make something happen before the end of the year or January.
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