Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA misses some performance goals. Device center issues ombudsman’s report. DePuy stops selling custom devices. More regulatory briefs.
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Regulatory News In Brief
The latest FDA guidances and other regulatory updates for device makers.
FDA Flexible On Data Sources, Techniques For Pediatric Device Claims
Computer modeling, Bayesian hierarchal modeling and use of off-label data sources are among novel methodologies that the device center may accept to demonstrate device effectiveness in kids, officials said Dec. 5.
Regulatory News In Brief
FDA user fee goals: Win some, lose some