Institute of Medicine Calls for More Regulation of Medical Devices

By:  Brian Koenig
08/01/2011
       
Institute of Medicine Calls for More Regulation of Medical Devices

A report released by the Institute of Medicine (IOM) calls for a sweeping overhaul of U.S. medical device regulation, challenging the FDA to broaden government oversight and enact stricter approval standards for thousands of devices — ranging from artificial hip and knee joints to bypass-surgery devices.

Originally commissioned by the FDA, the Institute of Medicine urged FDA officials last Friday to foster "a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices." The IOM protests that premarket screenings are far too lax, as current standards neglect to provide a thorough examination of the safety and effectiveness of medical devices.
 

A report released by the Institute of Medicine (IOM) calls for a sweeping overhaul of U.S. medical device regulation, challenging the FDA to broaden government oversight and enact stricter approval standards for thousands of devices — ranging from artificial hip and knee joints to bypass-surgery devices.

Originally commissioned by the FDA, the Institute of Medicine urged FDA officials last Friday to foster "a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices." The IOM protests that premarket screenings are far too lax, as current standards neglect to provide a thorough examination of the safety and effectiveness of medical devices.

Click here to read the entire article.
 

The JBS Weekly Member Update offers activism tips, new educational tools, upcoming events, and JBS perspective. Every Monday this e-newsletter will keep you informed on current action projects and offer insight into news events you won't hear from the mainstream media.
JBS Facebook JBS Twitter JBS YouTube JBS RSS Feed