“Study leveraged EHRs from two health systems, over 1,400 patients and was believed to be one of the first PMA label expansions based solely on EHR data”
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Said on FDA Watch
“Off-label standard of care use of the device in a population that was really too small for a traditional trial... resulted in a successful PMA label expansion”
FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
Play from 14:47
14:47
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What was described
secured a PMA label expansion for a mitral valve device to be used in the tricuspid position by combining multiple data sources through a data partner and a research partner
Said nearby on the same subject
“Make sure you have the right to the research, the right to use the data… data traceability all the way through the process.”
BH
Bethany Hills
FDA Watch ·
“We've been using their data… I've tested almost every data source… they are the most accurate of the data providers out there”
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Said on Profiles in Risk
“In Canada, U.S., you also have like these electronic data devices, electronic for logging hours. You're able to push messages through there for anything.”
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Said on The Site Shed | #1 Podcast For Tradies & Contractors
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