RWE Studies and Design Controls

I

Icculus

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#1
#1
I am working to start RWE studies via IRB with a medical device software application (SaMD). When deploying a non-significant risk devices for a RWE study, is the device considered an investigational device, and are quality system requirements/GMP expected or required?
 
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GAGEpack - Gage & Calibration Management
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chris1price

chris1price

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#2
#2
It depends on what the real world evidence is being used for. Take a look at the FDA guidance, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices", https://www.fda.gov/media/99447/download

"Whether the collection of RWD for a legally-marketed device requires an IDE depends on the particular facts of the situation. Specifically, if the device is being used in the normal course of medical practice, an IDE would likely not be required......................However, if data are being gathered to determine the safety and effectiveness of the device, and the process for gathering the data would influence treatment decisions, such administration would likely not be within the normal course of medical practice, and an IDE may be required. "

Whichever, QSR/GMP would be required.
 
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