Newly Released FDA Ultrasound System and Transducer Guidance
Section 5.2.6.1.8 – Does this Change the 3rd Party Service Question? G. Wayne Moore, B.Sc., MBA, FASE 07/09 /19 The new ultrasound Guidance document, https://www.fda.gov/media/71100/download, addresses, at least in part, two key issues related to the 3rd Party service docket that began some three years ago; specifically who can do service and remanufacturing and … Continue reading