FDCA, Anti-Kickback and False Claims Act, Implications of Investigator-Initiated Trials-Session 1
It is critical for the industry to understand the implications of reimbursement under the false claims act, as well as identifying when payment for an investigator initiated trial is deemed a kickback. Learn when the industry becomes a sponsor of an invetigator initiated trial and when an investigator trial requires an IDE.
Clinical data Requirement Changes-premarket clearance-Session 2
The paradigm shift to a world of clinical support for 510(k) submissions is jarring; the system had simply asked, is A like B, and now it must show that A is effective just as B was effective to demonstrate equivalence and the efficacy of today and tomorrow.