Study Results For Unapproved Devices Could Be Heading To ClinicalTrials.gov
This article was originally published in The Gray Sheet
Executive Summary
Under an NIH proposed rule, trial results for products or indications that have yet to be approved or cleared would be subject to posting requirements, with certain allowances for delay. Also, trial registrations for unapproved devices, currently hidden from view, could sometimes see the light of day before FDA acts.