The FDA today released a warning letter it sent to ReWalk Robotics (NSDQ:RWLK), formerly Argo Medical, over a failure to submit a post-market surveillance report on its ReWalk exoskeleton device addressing issues with injuries during falls while operating the device.
The agency detailed a string of back-and-forth communications between it and the ReWalk maker going back to July 31, 2014, when it submitted its 1st post-market surveillance study plan synopsis.
The robotic exoskeleton maker submitted the synopsis, but it was found to be deficient by the FDA and began a string of delays between the maker and the FDA that stretched to last summer, according to the warning letter.
In August, the company proposed “substantial changes to the methods and study plan” asked for an in-person meeting with the FDA. The FDA responded with a feedback letter in September, and recommended a revised post-market study plan “addressing this feedback and the deficiencies identified in the Agency’s February 13, 2015 letter as soon as possible.”
The agency said it has yet to receive a response to the request, nor a revised post-market study plan.
The FDA hit the company on a failure to submit a post-market study plan that addresses deficiencies laid out by the agency, failure to design a post-market study plan that answers the questions identified in its 522 order, failure to have an approved post-market study plan and failure to commence surveillance under section 522 of the act no later than 15 months after the day it was issued, according to its warning letter.
“Therefore, Argo has committed a prohibited act under section 301(q)(1)(C) of the Act by failing to comply with requirements under section 522 of the Act. Your firm’s ReWalk device, authorized for marketing under de novo classification (K131798/DEN130034), is currently misbranded under section 502(t)(3) of the Act,” the agency wrote in its letter.
The agency suggested the company correct the violations, and gave ReWalk 15 calendar days to respond. The FDA warned that failure to respond ”
may result in regulatory action being initiated by FDA without further notice,” including but not limited to seizure, injunction and civil money penalties.