'Least Burdensome' Comment Deadline Delayed By US FDA
The deadline has been bumped back to mid-March following a request from industry trade group AdvaMed.
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The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
The Senate approved the same 21st Century Cures bill passed by the House last week on a 94-5 tally; the bill is expected to be quickly signed by President Obama. Provisions for extra dollars for FDA in the bill means that even with a plan by Congress to adopt a continuing resolution this week freezing FDA funding until April 28, the agency can rely on an additional $20 million set aside for it in Cures in the new year.
The eight had ties to a group of Tennessee labs that reportedly paid physicians to order medically unnecessary testing, billing Medicare more than $150m in five years.