Optical coherence tomography (OCT) developer Optovue of Fremont, CA, is responding to a warning letter from the U.S. Food and Drug Administration (FDA) regarding a software feature on its RTVue OCT system.
The letter concerns a normative database (NDB) software feature on RTVue, which Optovue released using the FDA's "memo to file" process. After an inspection in December 2009, the FDA disagreed with the company's decision to use the memo to file process, and it asked the company to roll back the software to a previous version, effectively turning off the NDB feature.
Optovue will continue to ship RTVue without the NDB feature until it receives 510(k) clearance. The company has corrected any deviations observed and has performed a rollback of software installed in the field.
The company expects to receive 510(k) clearance for the NDB feature in August or September, according to John Talarico, vice president of regulatory and clinical affairs.
Related Reading
Optovue raises $10.5 million, April 3, 2007
Copyright © 2010 AuntMinnie.com
