FDA Approves Third-Party Invacare Audit; Company May Resume Some Activities

The Food and Drug Administration has accepted medical equipment maker Invacare’s submission of a third-party certification audit of some of the company’s design control systems at its facilities, the company said July 16.

Invacare said FDA’s acceptance will allow it to resume design activities for power wheelchairs and power beds.

The audit is the second of three third-party certification reports that FDA has signed off on, the company said, with a third audit of compliance with FDA’s quality system regulation at the facilities still in progress.

“We are proud to now have the FDA’s acceptance of two of the three ...