• Regulatory Affairs Professionals Society

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

The analysis, published in Nature Biomedical Engineering on Friday, raises questions about the trade-offs between speeding access to new devices and ensuring their safety.

Read the full article here.



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