IRBs Permitted to Reject IDE Study Approved by FDA, Agency Official Says

It is “perfectly acceptable” for an institutional review board to disapprove an investigational device exemption (IDE) study that the Food and Drug Administration has approved, as long as the IRB is clear on the agency’s reasons for its decision, an FDA devices official said during a Jan. 30 webinar.

Owen Faris was responding to a question about what to do when the IRB disagrees with the FDA’s conclusion that an IDE study may proceed either immediately or within 45 days after meeting specified conditions.

“IRBs have a mandate to make their own assessment. And it is perfectly acceptable for an ...