12

Oct

2006

Biolase Technology Inc

0

Recipient: Biolase Technology Inc.
Product:Medical and dental lasers
Date: 9/5/06

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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