FDA Guidance on Medical Device Voluntary Audit Report Submission Program
This post was written by Paul Sheives.
FDA has issued draft guidance on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This provision allows a device manufacturer that has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) using ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes,” to submit the audit report to FDA. If FDA determines there is minimal risk that the establishment will produce nonconforming and/or defective finished devices, FDA may elect to remove the manufacturer’s establishment from FDA’s routine work plan for one year. FDA is accepting written comments on the draft guidance until August 18, 2010.
