Things are handled differently on the pharma side. Section 505 of CFR Title 21 (which implements the Safe Food and Drug Act) lists cases where drug trials can

Things are handled differently on the pharma side. Section 505 of CFR Title 21 (which implements the Safe Food and Drug Act) lists cases where drug trials can commence; 505(b)(2) specifically allows the drug equivalent of a predicate device though they don't use that vocabulary. That allows the safety data of an existing drug to be used, which saves you time getting into Phase 1...and that's it. I agree that the approval of a tongue depressor shouldn't be complicated, but "not complicated" doesn't automatically imply "anything goes". I have long believed that a lot of 510(k)s should really be PMAs.