Chicago heart surgeon’s retroactively approved device prompts senator’s inquiries to FDA

Senator pushes FDA on medical device guidelines

CHICAGO — A prominent U.S. senator is pushing for federal action to close a loophole in Food and Drug Administration guidelines for new medical devices.

Iowa Republican Chuck Grassley is asking the FDA for an immediate update on plans for new guidelines. Grassley released his letter Wednesday.

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

Northwestern’s attorneys say it is the device maker’s duty to ensure is has been cleared by the FDA, not the duty of the hospital or the surgeon.

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

On the Net: finance.senate.gov/