Update at Invacare: FDA moves on

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Friday, April 21, 2017

ELYRIA, Ohio – The U.S. Food and Drug Administration will now pick back up on a third and final certification report submitted by Invacare’s third-party auditor.

The FDA on April 13 notified Invacare that it has accepted an updated second certification report submitted by the company’s third-party auditor, allowing it to resume design activities at its corporate headquarters and Taylor Street manufacturing facilities in Elyria.

“It’s good to have this milestone, but there’s more work ahead,” said Lara Mahoney, Invacare’s senior director of investor relations and corporate communications.

The FDA had originally accepted a first and second certification report in 2013, but after a follow-up inspection in 2015, the agency told Invacare it had more work to do. That work included applying its design control process to additional products and remediating certain design history files, Mahoney says.

Invacare’s third-party auditor submitted a third and final certification report to the FDA in February 2016, but that was “essentially paused” until work was completed on the second certification report, Mahoney says.

“Now that the FDA has accepted the updated second certification report, we are able to proceed,” she said.

The acceptance of the third and final certification report, which relates to Invacare’s entire quality system, will pave the way for lifting a consent decree that has limited the company’s ability to manufacture and sell certain products since 2012. Invacare must also submit its own report detailing its remediation work over the years, and the FDA must re-inspect the facilities.

“The big question is how long all of this will take,” Mahoney said. “It’s hard for us to say.”

In the meantime, the clearance to resume design activities couldn’t come at a better time for Invacare. The company plans to launch an update to its TDX line of power wheelchairs later this year.

“It’s important,” Mahoney said, “as we are now able to proceed with new design and product development work at the Taylor Street facility. This includes transferring the design of our new TDX SP2 power wheelchair to the facility and getting it into production there later this year.”