FDA WARNING_LETTER - Argo Medical Technologies Inc.

On September 30, 2015, the FDA issued a Warning Letter to Argo Medical Technologies, Inc. regarding its failure to comply with post-market surveillance requirements for the ReWalk device (K131798/DEN130034). The FDA authorized marketing of the ReWalk device on June 26, 2014, and simultaneously ordered Argo to conduct post-market surveillance under section 522 of the Federal Food, Drug and Cosmetic Act (the Act) and 21 CFR Part 822 (Order PS140001). This order was issued due to the device's potential to cause serious user injury or death from falls.

Argo submitted a PS study plan synopsis on July 31, 2014, which the FDA found deficient on September 29, 2014, requiring a complete response within 30 days. Argo failed to respond. A subsequent submission on November 6, 2014, was also found deficient on February 13, 2015, with another 30-day response deadline missed. Despite multiple FDA communications and attempts to coordinate, Argo failed to provide an adequate revised study plan or commence the surveillance study.

The FDA cited Argo for: * Failure to submit a revised PS study plan addressing deficiencies (21 CFR 822.19).