The FDA announced that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components. Once the consent decree is entered into the court, Invacare will not be able to resume normal business operations at two of its Elyria, Ohio, facilities until it corrects all violations listed in the consent decree and it has been notified by the FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act (the Act).
The Act requires medical device companies to follow current good manufacturing practice and to follow strict guidelines in reporting adverse events to the FDA. To comply with current good manufacturing practice, a medical device company must establish and follow specific procedures, which are outlined in the FDA’s Quality System regulations, to prevent quality problems in their devices. Seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of the FDA’s Quality System regulations, along with failures to properly report adverse events to the agency.
The consent decree also requires Invacare to retain a third-party expert to help it develop and submit plans to the FDA to correct the violations found by the agency. Once Invacare receives permission from the FDA to resume manufacturing and distributing, the company must continue to submit audit reports to the agency for five years to verify continuing compliance. In addition to these audit inspections, the FDA will monitor the company’s activities through its own inspections.
The parties filed the consent decree, which was signed by Invacare’s president and chief operating officer and the company’s director of Product Risk and Quality Engineering, in the United States District Court for the Northern District of Ohio on Dec. 20, 2012. If the defendants violate the consent decree, then the FDA may order Invacare to cease manufacturing, recall products, and take other corrective action, and the agency may levy fines of up to $7 million annually.
See the FDA Announcement