I think this is a portraying an emergency situation which would require a quick Yes or No to use an unapproved medical device. I think as we learned with IRB, that it would also need IRB clearance. I can’t think of many hospitals in the tri-state area that would allow one of their physicians to treat a patient with an unapproved device that wasn’t IRB approved/FDA approved. From a legal perspective, that would really expose the hospital because if something happened, they would end up in NY Times and would incur a lot of legal expenses. Non-profits are risk averse and would not condone such use of unapproved devices. However, this almost then becomes an ethical dilemma for the physician in how to provide the best care. I think it is a very tough call, but I personally don’t’ think that this situation arises in hospitals a lot because there are so many formal procedures and approvals like IRB approval that this wouldn’t even be a consideration. I think as others have mentioned for HDE and other pathways to formalize pathways for compassionate use cases.

As @amin-sadig mentions Trump’s “Right to Try” agenda for terminally ill patients that “would allow patients to access experimental drug treatments that bypass the Food and Drug Administration’s clinical trial process.” Article from CNBC in February:

cnbc/2018/02/21/president-trumps-support-for-risky-experimental-drugs-sidesteps-fda

I think it will be interesting to see if this Right to Try law passes and what the implications will be for this. Will it set the stage for changing some FDA approval timelines?