The U.S. Food and Drug Administration (FDA) has updated its guidance for manufacturers seeking marketing clearance for diagnostic ultrasound systems.
Among the changes from the 1997 guidance, the FDA no longer recommends the submission of a 510(k) Special Report if the manufacturer maintains acoustic output measurements and labeling records in their design history file. Previously, the agency stated that any substantial equivalence decision should be followed by a 510(k) Special Report prior to shipping the device.
The guidance also adds appendices addressing non-OEM replacement transducers and reprocessed "single-use-only" transducers, as well as revised recommended labeling for cleaning and disinfecting transducers. The complete revised guidance can be found here.
Related Reading
Definity echo contrast agent lands on FDA drug safety list, September 8, 2008
FDA formally updates echo contrast black box warning, July 18, 2008
FDA ultrasound contrast safety meeting sparks discussion, hope for the future, July 10, 2008
More study of heart imaging agent risks urged, June 25, 2008
Concerns remain over heart imaging agents: U.S. FDA, June 20, 2008
Copyright © 2008 AuntMinnie.com
