Invacare has more work to do, FDA says
ELYRIA, Ohio – Invacare has hit a bump in the road in its goal of lifting a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.
Invacare previously reported in February of this year that an independent auditor had issued a certification report for the third and final phase of the decree. The company planned to submit its own report and seek approval for both reports from the FDA.
On June 7, however, Invacare received a letter from the FDA outlining additional steps that the company must take before moving forward, including completing the remediation of certain design history files referenced in the FDA’s 2015 inspection report and in the decree.
“Before the company can design any new Taylor Street wheelchair devices, the specified DHFs must be completed, then recertified by the company’s third-party expert, whose updated report must be accepted by the FDA,” Invacare stated in a Form 8-K filed with the Securities and Exchange Commission on June 8. “The FDA also has clarified that its acceptance of the expert’s updated report on these DHFs is a prerequisite to proceeding further with the third certification process.”
Design history files describe the methods used to design and test a product, as well as the processes that ensure those methods are properly followed.
Invacare said the FDA’s feedback is “aligned with work already underway.”
The company also said it does not expect the FDA’s letter to “materially impact” its upcoming second quarter financial results.