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The FDA Tag

The DOJ Will Huff & Puff About The Sunshine Act But Not Blowing Any Houses Down

Updated July 1, 2015 July 18, 2014 Earlier this week the AMA announced that physicians have between now and August 27 to review reports about their financial interactions with  manufacturers of drugs and medical devices and dispute potentially inaccurate reporting under the Physician Payments Sunshine Act (also known as...

What Happens if the FDA Revokes a 510K Should All Predicate Devices Follow?

June 3, 2014 The 510 (K), is a clearance the government gives to medical devices based off of substantially equivalent  or similar device (known as a  predicate device) already placed into one of the three classification categories.  To super simplify let's say a Crazy Straw was a new medical...