Does the FDA have to approve EVERYTHING?

Listening to NPR on the car radio today.  A medical guy was describing an off the wall procedure which had worked well in some cases.  It did not involve the use of commercially marketed drugs at all.  But, the voice over commentator at the end of the piece said something like "This innovative procedure won't go anywhere until the FDA approves it."  
   Excuse me.  I thought a license to practice medicine granted to the right to treat patients.  In this case the treatment worked.  I fail to see where the FDA has any authority to approve , disapprove, or demand more paperwork on a procedure that does not involve prescribing any sort of drug.