Balancing Benefit and Risk in Medical Device Regulation

Balancing Benefit and Risk in Medical Device Regulation

Source: 
FDA Law Blog
snippet: 

Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago.

At the same time, these medical devices can pose risks to patients that sometimes lead to injuries even if, on net, the benefit of the device exceeds the risk.