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510 (k) Tag

FDA is Illegally Allowing The Off-Label Promotion of Medical Devices

November 11, 2016 Yesterday, as the last speaker of the morning session during FDA Public Hearing on off-label for pharmaceuticals and medical devices and, just prior to my approaching the podium, Commissioner of FDA, Dr. Robert Califf noticeably and rather cowardly left the room.  The one...

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...

Is a 510 (k) a Race? Sort Of.

Well, I guess it’s safe to come clean now.  I cheated on my French test in high school by conjugating the verbs on suede shorts I bought with the intention to cheat.  Right before the test I wrote the verb tenses with my finger on...