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BioWorld - Tuesday, March 24, 2026
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Home » Duration of spinal study follow-up may be tweaked after FDA workshop
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Duration of spinal study follow-up may be tweaked after FDA workshop

Oct. 11, 2021
By Mark McCarty
The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.
Medical technology Regulatory Orthopedics U.S. FDA

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