Recipient: Biolase Technology Inc.
Product:Medical and dental lasers
Design output procedures do not allow for an adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). Specifically, the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the corresponding functional outputs.
Procedures were not completed to ensure that the device design was correctly transferred into production as required by 21 CFR 820.30(h). Specifically, the design transfer procedures have not included explicit instructions to transfer the software requirement specifications to production. The software requirement specifications for the Waterlase MD design project were not transferred to production in November 2004 when most other specifications and procedures were transferred. Finished Waterlase MD dental lasers began to be commercially shipped in December 2004, but the software requirements were not transferred to production until April 20, 2005.
FDA District: Los Angeles District Office