Comment from dihua xu
AnonymousSupportIndividual
Summary: The commenter suggests a revision to the draft guidance to broaden the scope of language regarding concomitant treatments. They argue that the current phrasing focuses too narrowly on "device" safety and efficacy and should instead encompass the "clinical investigation" as a whole to be consistent with the guidance's application to both drugs and devices.
line 146-148, "Administration of concomitant treatment prohibited by the study protocol that may increase risks to participants (e.g., drug-drug interactions) and/or impact interpretation of a device’s safety and efficacy." This language appears to suggest that concomitant treatment may only impact the interpretation of a device's safety and efficacy. However, since these guidelines apply to both drugs and devices, it may be more appropriate to revise the phrasing to reflect this broader scope: recommend revising the sentence to “...and/or impact interpretation of the clinical investigation.”