The FDA has hit a developer of a system designed to help patients walk with a warning letter for failing to provide timely updates to its postmarket surveillance plans.
ReWalk Robotics — formerly known as Argo Medical Technologies — received the Sept. 30, 2015, warning letter for not correcting deficiencies in its postmarket surveillance studies, despite several FDA requests. The company had until Sept. 28, 2015, to have its postmarket surveillance plan approved under Section 522 of the Federal Food, Drug and Cosmetic Act.
The letter states that the FDA allowed marketing of ReWalk under de novo classification June 26, 2014, and issued a 522 order for the company to conduct postmarket surveillance of the device. Specifically, the agency asked for a registry to collect data on adverse events related to ReWalk use and assess the adequacy of its training program. The FDA wanted to assess the risk of a patient or someone assisting that person falling down and sustaining a serious injury.
ReWalk submitted a postmarket plan, which the FDA received July 31, 2014. Roughly two months later, the agency informed the company that the submission lacked certain information and asked for a response within 30 days. ReWalk failed to submit a response within that timeframe, according to the warning letter.
The FDA followed up Nov. 5, 2014, informing ReWalk that the response was overdue. The company submitted an updated plan the following day; however, the agency informed ReWalk in a Feb. 13, 2015 letter that there were deficiencies in the plan and requested a follow-up. According to the FDA, the company again failed to respond within the 30-day timeframe.
This pattern continued in 2015, according to the letter, with the company not following up with a plan by April 15, 2015. ReWalk did reply May 22, 2015, saying it was ready to respond to all but one issue. It asked to discuss the issue with FDA staff before submitting a formal response.
“FDA attempted multiple times [via phone and email], from June 12, 2015 to July 28, 2015, to coordinate the requested teleconference with your firm in an attempt to resolve the outstanding issues,” the letter states. “FDA also notified you in an email dated June 24, 2015 that the Agency considered Argo’s 522 study to be out of compliance.”
ReWalk followed up July 29, 2015, stating that it would propose dates in early August for the teleconference. However, the company notified the FDA that it had made “substantial changes to the methods and study plan,” adding that it would like a face-to-face meeting with agency staff regarding the “major proposed changes.”
In September, the FDA offered feedback on the changes, and requested a reworked postmarket study plan that addressed concerns outlined in the Feb. 13, 2015 letter. According to the letter, the FDA had heard nothing as of Sept. 30, 2015. Further, ReWalk “has not submitted a revised study plan, and there has been a substantial lack of progress towards commencement of the 522 PS study required under the 522 Order.”
The warning letter asked ReWalk to submit its 522 postmarket surveillance study plan within 15 days of receiving the letter to address the deficiencies identified in the previous communications from the FDA.
“ReWalk Robotics responded within 15 business days to the FDA warning letter dated September 30, 2015, and the company has been in regular communication with the FDA in the intervening months to resolve all issues tied to the post-market study,” ReWalk CEO Larry Jasinski said. “Restructuring the format of the study has raised additional conversations, and ReWalk is confident we will be able to reach a resolution that meets the requirements of the FDA 522 order.”