FDA lifts Invacare’s consent decree

Decree has handicapped company since late 2012
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Tuesday, July 25, 2017

ELYRIA, Ohio – Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25.

A consent decree with the U.S. Food and Drug Administration has limited Invacare’s ability to make and sell products from the facilities for nearly five years, since December 2012.

“Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United States, the subject devices at or from corporate or Taylor Street facilities,” the FDA stated in a letter to the company dated July 24.

The letter follows the FDA’s re-inspection of the facilities in late May. Prior to the re-inspection, the FDA received and approved three certification reports from Invacare’s third-party auditor.

To ensure continuous compliance, the FDA now requires Invacare to undergo five years of audits by an auditor. The company says an auditor will inspect the facilities every six months for the first year, and then once every 12 months for the four years thereafter.

“We made significant investments in our quality system, as well as manufacturing and design processes,” said Matthew Monaghan, chairman, president and CEO, in a press release. “We are pleased to have the FDA’s recognition of our progress, and we will continue to put quality at the core of everything we do.”

Now that the FDA has lifted the consent decree, Invacare can sell wheelchairs designed and manufactured at the Taylor Street facility without having to obtain verification of medical necessity documentation. The timing couldn’t be better: The company recently received 510(k) clearance from the FDA for its TDX SP2 power wheelchair with LiNX Technology and will launch the product in the third quarter of this year.

“We look forward to expanding our rehab business over time,” Monaghan said.