Invacare Corporation Receives FDA Acceptance of Second Certification Audit Related to Consent Decree

Invacare Corporation IVC today announced that the United States Food and Drug Administration (FDA) has found acceptable the Company's second third-party certification audit relating to design control systems at the Company's Corporate and Taylor Street facilities. This acceptance permits the Company to resume design activities for power wheelchairs and power beds. ''We are proud to now have the FDA's acceptance of two of the three third-party certification reports,'' said Gerald B. Blouch, president and chief executive officer. ''Our engineering resources will continue to be committed to our quality systems remediation until we fully demonstrate our quality systems compliance to the FDA and resume full operations at the Taylor Street manufacturing facility in Elyria, Ohio. However, this acceptance permits us to resume design activities on the critical new product development projects that will help us regain our custom power wheelchair market share when we exit the injunctive phase of the consent decree.'' The remaining third-party certification audit is a comprehensive review of the Company's compliance with the FDA's Quality System Regulation at the impacted Elyria facilities. The Company originally set an aggressive goal of completing this audit by June 30, but, in light of the scope and complexity of the audit, the Company is re-evaluating its expected timing of when the report will be completed and filed with the FDA. The Company is devoted to successfully completing this audit in a timely manner. After the certification report relating to this audit is submitted to the FDA, the agency will conduct its own inspection of the facility. Once the Company receives written notification from the FDA that the Corporate and Taylor Street facilities appear to be in compliance, the Company may resume full operations at those facilities. Commenting on the final third-party certification audit, Blouch continued, ''While we were pleased with the progress that we had made on the final third-party certification audit, we have identified a few areas in our quality system that require additional work. We need to take the time now to reassess these sections of our quality system to ensure the processes we have put in place are sustainably compliant. Be assured that we will complete these improvements with the same determination and commitment with which we achieved the first two audits. I sincerely thank our associates for their continued dedication and passion to making Invacare an even stronger company.'' The Company will give an update on the final third-party certification audit in its July 25, 2013 second quarter earnings release. Invacare Corporation IVC, headquartered in Elyria, Ohio, is the global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. The Company has 5,800 associates and markets its products in approximately 80 countries around the world. For more information about the Company and its products, visit Invacare's website at www.invacare.com.