Senator: Regulators and Medical Device Manufacturers Must Find Common Ground
Posted 13 April 2012 | By
Minnesota Senator Al Franken (D-MN) told media present at the Design of Medical Devices Conference he doesn't believe there needs be a choice between having medical devices be proven safe or having those devices be brought to market quickly, reports The Star Tribune.
"To some degree, there is a false choice there," said Franken, a member of the Senate Health, Education, Labor and Pensions Committee which oversees the US Food and Drug Administration.
The way forward, explained Franken, lies in getting regulators and industry to sit down to find the best way forward so patients can receive safe and effective treatments as quickly as possible.
"These people better start talking to each other," explained Franken. "I want to be a bridge there" to make improvements in the Premarket Approval and 510(k) medical device approval pathways.
For Franken, though, it's clear he believes the approval times for medical devices are taking too long.
"The longer things take to get to market, it makes the thing not cost-effective to do in the first place," said Franken. "There are people who need these devices."
The Star Tribune - Franken says U.S. can improve medical device approval process while ensuring safety