- 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.