FDA WARNING_LETTER - Bioptigen Inc

The FDA issued a Warning Letter to Bioptigen for marketing its High Performance Pediatric SD-OCT Hand-held Imaging System in the U.S. without required marketing clearance or approval. The firm had a 510(k) clearance (K063343) for a tabletop Spectral Domain Ophthalmic Imaging System. However, Bioptigen modified the device to a handheld scanner and promoted new diagnostic uses, such as for Retinopathy of Prematurity, Pediatric Retinoblastoma, and Shaken Baby Syndrome, via its website and brochures. The FDA deemed these changes significant under 21 CFR 807.81(a)(3), placing the device outside its original clearance. Consequently, the device is adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under section 502(o) of the Act for failing to submit a 510(k) notification for the modified device. Bioptigen must promptly correct these violations and respond within fifteen working days, detailing corrective actions and prevention plans. Failure to comply could result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. This letter specifically addresses premarket review obligations.