MASSDEVICE ON CALL — Some major healthcare industry players are looking to the FDA to provide more robust surveillance of medical devices on the U.S. market.
The group asked the FDA to look over a handful of recommendations for boosting medtech registries to gather more robust information about devices that have already been approved or cleared, saying that such measures could track safety issues.
Several groups, including the Blue Cross & Blue Shield Assn., the Pew Charitable Trusts and the Science Infrastructure Center run by Weill Cornell Medical College’s Medical Device Epidemiology Network.
"It’s taken us too long to figure out these devices have serious and unexpected safety problems," Pew medical device director Dr. Josh Rising told Modern Healthcare. "There’s no reason that we shouldn’t be able to identify these problems in the United States."
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Korean smartphone glucometer reaches the U.S.
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