Looks like Gottlieb is plugging progress on CDRH's precert pilot program: "We’re making available the first draft of our Working Model, which provides our vision on various aspects of the program and our steps for expanding it." #HDPalooza
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Transcript says @SGottliebFDA will announce that "We’re committed to launching “Pre Cert 1.0”, a first version of the program by the end of 2018. Once we get this framework firmly in place, it’ll be further refined in 2019." #HDPalooza
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FDA is also looking at how digital health tools can be used as part of approved drugs similar to the precert program. "We’ll clarify that not all FDA requirements apply every time a digital health tool is employed in relation to a prescription drug," @SGottliebFDA announcing.
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If you're looking for the Federal Register links for the guidances being discussed by @SGottliebFDA at #HDPalooza:
Multiple Function Device Products: Policy and Considerations: s3.amazonaws.com/public-inspect
Clinical Trial Imaging Endpoint Process Standards: s3.amazonaws.com/public-inspect
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Also, if you're looking for the roadmap for Pre Cert 1.0 @SGottliebFDA is discussing at #HDPalooza, you can find FDA's slide here: fda.gov/downloads/Medi
More info on the program is here: fda.gov/MedicalDevices
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Also @SGottliebFDA announces the "creation of an internal data science incubator called the Information Exchange and Data Transformation; or INFORMED" to help "regulatory science research in areas related to health technology and advanced analytics related to cancer." #HDpalooza
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INFORMED will "look at developing new clinical endpoints and signal detection methods for evaluation of the safety and effectiveness of therapies ... [to understand] variations in individual patient experience using diverse data sets," @SGottliebFDA says at #HDPalooza.
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