21 CFR 26.9 - Equivalence determination.
(a) Equivalence is established by having in place regulatory systems covering the criteria referred to in appendix D of this subpart, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g., postapproval or preapproval) or product classes or processes.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.