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Senator pushes FDA on medical device guidelines
Posted: 02.17.2010 at 2:20 PM
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CHICAGO, ILL. (AP) -- A prominent U.S. senator is pushing for federal action in response to a case involving a star Chicago surgeon.

Iowa Republican Chuck Grassley is asking the Food and Drug Administration for an immediate update on plans for new guidelines for medical device makers.

Grassley released his letter Wednesday.

Grassley says he's following up on questions he asked more than a year ago, after a heart device was implanted in patients at Northwestern Memorial Hospital without proper FDA clearance.

Northwestern's attorneys say it was the device maker's duty to make sure it had proper FDA clearance - not the duty of the hospital or the device's surgeon-inventor.

Northwestern issued a statement Wednesday supporting Grassley's request for more clarity in the device approval process.

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On the Net:
 http://finance.senate.gov/

(Copyright ©2010 by The Associated Press. All Rights Reserved.)

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