Report of Changes

Report of Changes. The registrant shall notify the Agency in writing before making any change which would render the information reported pursuant to 6.1.4(2)(a), (b) and (c) contained in the application for registration and/or the certificate of registration, no longer accurate. This requirement shall not apply to changes involving replacement of designated original equipment lamp types with lamps which have been certified with the FDA as "equivalent” replacement of the lamps. The facility owner shall maintain manufacturer's literature demonstrating the equivalency of any replacement lamps.