FDA WARNING_LETTER - Optovue Inc. - January 08, 2010

During an FDA inspection from December 8, 2009, to January 8, 2010, Optovue, Inc., manufacturer of the RTVue Optical Coherence Tomography (OCT) with Normative Database (NDB), was found in violation of federal regulations. The RTVue OCT with NDB, a device for retinal imaging and diagnosis, was deemed adulterated because Optovue lacked an approved premarket approval (PMA) or investigational device exemption (IDE). It was also misbranded for failure to submit a 510(k) premarket notification.

The inspection revealed additional misbranding due to failure to establish written Medical Device Reporting (MDR) procedures (21 CFR 803.17) and inadequate training for employees responsible for complaint review. The firm also failed to comply with Quality System (QS) regulation (21 CFR Part 820), including: 1. Failure to validate device software (versions 3.5 and 4.0), with documented test failures, unaddressed critical defects, and missing/incomplete test data. 2. Failure to verify design outputs meet design input requirements, specifically regarding the NDB's clinical study design and data inclusion. 3. Failure to implement compliant handling procedures for device failures reported in servicing records, clinical study reports, and marketing questionnaires. 4. Failure to establish procedures for evaluating complaints for MDR submission