FDA sent Argo Medical Technologies Inc. a warning letter outlining the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The letter also details how the manufacturer dodged multiple communication attempts made by the agency.

FDA authorized the marketing of the ReWalk motorized exoskeleton under a de novo classification on June 26, 2014, the warning letter states, noting that FDA used its authority under Sec. 522 of the Food, Drug and Cosmetic Act to execute the postmarket surveillance study order on the same day. (See [A#01140630014].)

At about the same time, Argo changed its name to ReWalk Robotics Ltd.

“ReWalk Robotics ... has been in regular communication with the FDA in the intervening months to resolve all issues tied to the postmarket study," CEO Larry Jasinski says.

The letter was posted on FDA's website on March 1 but written to Argo on Sept. 30, 2015. It notes that the ReWalk device is misbranded because of Argo's failure to act on the study.

The agency can require Sec. 522 studies when a high- or moderate-risk device is likely to cause serious adverse health consequences if it fails, or is intended to be a life-sustaining or life-supporting device, among other reasons.

The postmarket surveillance order for ReWalk was issued because a patient could fall if the device fails, potentially leading to traumatic brain injury, spinal cord injury and fractures. People assisting the patient could also be injured.

The agency has issued warning letters for failure to comply with Sec. 522 study obligations in the past, but they're extremely rare. The last time a firm received such a missive was in January 2011; Alphatec Spine Inc.was the recipient. (See Also see "Rare Warning Letter Cites Alphatec For Post-Market Study Non-Compliance" - Medtech Insight, 31 January, 2011..)

FDA's performance in ensuring the start and completion of post-approval studies, including 522 studies, has come under scrutiny by Congress and others. (See [A#01151109002].)

The missive to Argo lays out a timeline of events that describes how the agency chased after the company:

June 26, 2014: FDA orders a postmarket study related to ReWalk.
July 31, 2014: Argo submits a postmarket surveillance study plan to FDA.
Sept. 29, 2014: FDA sends a letter to Argo noting that its submission lacked specific information needed to complete the review of the firm's Sec. 522 plan. The agency asks the manufacturer to respond within 30 days.
Nov. 3, 2014: FDA notifies Argo that its response is overdue.
Nov. 6, 2014: Argo sends a letter to the agency that includes a second postmarket surveillance study plan.
Feb. 13, 2015: FDA once again sends a letter to Argo noting that its second submission lacks specific information. The agency asks the firm to respond within 30 days.
March 16, 2015: The agency again notifies Argo that its response is overdue.
March 20, 2015: Argo tells FDA that it will respond by April 15, 2015. It doesn't.
April 16, 2015: FDA requests a status update.
May 22, 2015: Argo says it is ready to respond to all but one issue raised by the agency and asks to discuss that issue with FDA staff before submitting a formal response.
June 12-July 28, 2015: FDA makes multiple attempts via phone and email to coordinate Argo's requested teleconference.
June 24, 2015: FDA tells Argo that its Sec. 522 study is out of compliance.
July 29, 2015: Argo replies to FDA's request for a teleconference, and says the firm will have proposed dates for the teleconference by the week of Aug. 3, 2015. It doesn't.
Aug. 10, 2015: Argo tells the agency that it is proposing substantial changes to the study plan and requests an in-person meeting with FDA if it has questions regarding the changes.
Sept. 2, 2015: FDA recommends that the firm submit a revised postmarket surveillance study plan that addresses deficiencies outlined in the agency's Feb. 13, 2015, letter.

As of the date of the warning letter, the agency had no further communication with Argo. Further, the firm didn't submit a revised study plan and there has been a lack of progress toward starting a Sec. 522 study, the letter states.

Under Sec. 522, a manufacturer must begin a postmarket surveillance study no later than 15 months after the day when the study was ordered. Argo's 15-month timeframe ended on Sept. 28, 2015; the warning letter was issued two days later.

Subsequent to the warning letter, ReWalk Robotics says it has made progress with 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 postmarket study," said Larry Jasinski, CEO of ReWalk. "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: Exoskeleton Firm Dodged Communication With FDA Over Postmarket Study, Failed To Assemble Surveillance Plan

More from Regulation

More from Policy & Regulation