The FDA today said it reclassified RebiScan’s handheld pediatric vision scanner device as a Class II device.
RebiScan’s flagship PVS won FDA de novo clearance in June, with indications for screening young children for amblyopia and strabismus.
Boston-based RebiScan put in a request to classify the device as Class II in December 2013, according to the FDA.
The agency issued an order classifying the device in Class II on June 8, according to the release, and laid out its special controls for the device, which has been labeled under a generic name as a strabismus detection device.
The federal watchdog identified 5 possible risks, including diagnostic risks such as false positives, false negatives and no outputs, electromagnetic interference, electric shock, ocular light toxicity and user error.
To manage diagnostic risks, the FDA said it will require mitigation measures including clinical performance testing, software verification and hazard analysis and appropriate labeling.
Electromagnetic compatibility testing and electrical safety testing were identified as measures to mitigate electromagnetic and electric shock risks. Software verification and validation, hazard analysis and optical radiation safety testing were identified as measures to mitigate ocular light toxicity risks.