No. IRB registration is not a form of accreditation or certification by FDA that the IRB is in full
compliance with 21 CFR Part 56. While a U.S. IRB that reviews FDA-regulated studies must
register to be in compliance with 21 CFR Part 56.106(a), IRB registration does not address issues
regarding an IRB’s competence or expertise nor does it require IRBs to meet a particular
standard in order to conduct a review.