The company said that the letter followed the completion of multiple procedural milestones, including an on-site inspection of the facilities by the FDA on May 30.
“Since I arrived at Invacare in 2015, we have created a culture of quality excellence. We made significant investments in our quality system, as well as manufacturing and design processes. We are pleased to have FDA’s recognition of our progress, and we will continue to put quality at the core of everything we do. I want to thank our associates and acknowledge the leadership of John Watkins, senior vice president of quality assurance and regulatory affairs, for making quality our number one priority and getting us to this important milestone,” prez & CEO Matthew Monaghan said in a prepared statement.
Invacare said that with the approval, it will now be able to sell wheelchairs designed and manufactured at the facility without needing to obtain verification of medical necessity documentation that it was previously required to do under the consent decree.
The company said that under its new consent decree with the FDA it will be required to undergo 5 years of audits by a 3rd party auditor selected by Invacare, which will inspect the facilities every 6 months for the 1st year then once a year for the 4 years after.
Invacare specified that its other manufacturing facilities were unaffected and remain operational.
“The consent decree was a precipitating event for Invacare, and it caused us to evaluate all areas of the business. We are emerging from this experience with a new, stronger foundation. While our transformation remains ongoing, we now have a leadership team with robust medical device and quality backgrounds; a clear transformation strategy that aligns the company toward its more clinically complex mix of products; a new commercial focus on our clinical competencies to better meet the needs of our complex rehab and post-acute customers; and an exciting new product portfolio. This new product portfolio includes the Invacare TDX SP2 power wheelchair with LiNX technology, which recently received 510(k) clearance from FDA and will launch in the third quarter of 2017 from the Taylor Street facility. We are very proud to have reached this consent decree milestone with FDA, and we thank the many customers who have remained committed to us throughout this process. We look forward to expanding our rehab business over time and working together with our customers to make life’s experiences possible for the people who need our products,” Monaghan
said in a press release.
Last month, Invacare said it closed its manufacturing facility in Suzhou, China as it continues along the 2nd phase of a strategic transformation.