The FDA has completed the setup of a new pilot program that will exempt medical device manufacturers from certain quality auditing for one year if they voluntarily submit satisfactory audit documentation. The program is set to launch June 5.
To get the exemption under the program, which debuted in draft form in May 2010, device makers must provide auditing records demonstrating compliance of their quality-management system with ISO 13485:2003, the international standard specifying conditions by which a quality-management system demonstrates a medical device manufacturer’s ability to consistently meet customer and regulatory requirements.
As the pilot program’s final guidance document puts it, the voluntarily submitted documentation needs to show evidence pointing to “minimal probability … that the establishment will produce nonconforming and/or defective finished devices.”
The guidance documents describing the program, Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program, cover who is eligible for participation, what kinds of audit reports are acceptable for submission, how manufacturers should submit audit reports and what FDA will do with submissions.
The program is open to foreign as well as domestic manufacturers as long as they have been previously audited under a regulatory system implemented by a founding member of the Global Harmonization Task Force. These include the Canadian Medical Devices Conformity Assessment System, Notified Bodies designated by member states of the European Union, the Australian Therapeutics Goods Administration and the Japanese Ministry of Health, Labour and Welfare.