Invacare can resume design activities
ELYRIA, Ohio – Invacare has been given the green light to resume design activities, according to a Form 8-K filed with the Securities and Exchange Commission.
On April 13, the U.S. Food and Drug Administration accepted a recent second certification report submitted by Invacare’s third-party expert relating to design control requirements at its corporate headquarters and Taylor Street manufacturing facilities in Elyria, Ohio.
“The company is pleased to have achieved this milestone and believes it reflects the company’s continued emphasis on building a quality culture as part of its long-term transformation,” Invacare states in the form.
A consent decree with the FDA has limited Invacare’s ability to design and manufacture wheelchairs at the two facilities since 2012.
Invacare must still get the FDA to accept a third certification report.