FDA Warns Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures

Posted 01 March 2016 By Zachary Brennan

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Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs.

The warning letter is for the company’s Massachusetts site, which opened in 2012, and details how the company consistently avoided FDA requests for more than a year.

The avoidance of FDA came after the agency issued what’s known as a “522 Order” for post-market surveillance studies “because the device’s failure to prevent a fall would be reasonably likely to cause serious user injury and/or death through fall related sequelae, such as traumatic brain injury (TBI), spinal cord injury (SCI), and fractures to the user. In addition, an individual assisting the user could also be placed at risk of harm from a potential fall,” FDA said. 

Among the issues raised, the agency says Argo, which has been re-named ReWalk Robotics, has failed to:

  • Submit a revised post-market surveillance study plan that adequately addresses the deficiencies described in FDA’s 29 September 2014 letter, as well as those deficiencies described in FDA’s 13 February 2015 letter;
  • Design a post-marketing study plan that answers the questions identified in the 522 Order;
  • Have an approved post-marketing study plan; and
  • Commence surveillance not later than 15 months after the day on which the 522 Order was issued.

Communication Failures

In addition to the failures of Argo in its post-marketing surveillance, the company consistently failed to respond to FDA requests for more information.

FDA notes that after issuing the 522 Order, the company offered a post-market surveillance study plan that was rejected by FDA with multiple deficiencies. A second study plan was also found to be deficient.

Again, FDA said the firm’s response to the deficiencies was overdue and “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.”

On 29 July 2015, Argo said via email that it would propose dates for a teleconference but then a week later, Argo “notified FDA for the first time” that it was proposing substantial changes to the methods and study plan and requested an in-person meeting with FDA.

The agency later called on Argo to submit a revised post-marketing study plan addressing this feedback and the deficiencies identified in FDA’s February 2015 letter as soon as possible. 

“To date, FDA has received no response to this communication from your firm, Argo 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,” according to the September warning letter released Tuesday.

CEO Larry Jasinski told Focus: “ReWalk Robotics [previously known as Argo] 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. 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.”

Warning Letter

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Categories: Medical Devices, Crisis management, Due Diligence, Manufacturing, Postmarket surveillance, Quality, News, US, Middle East, CDRH

Tags: Argo Medical, ReWalk Robotics, FDA warning letter, 522 Order

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