Regulatory Focus™ > News Articles > FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions

FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions

Posted 16 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is announcing the creation of a pilot program to expedite voluntary audit report submissions for medical devices.

Under the pilot program, a device manufacturer may voluntarily submit an audit report to FDA so long as their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using:

  • International Organization for Standardization (ISO) 13485:2003 "Medical devices - Quality management systems - Requirements for regulatory purposes" and
  • and ISO 13485:2003 Technical Corrigendum 1:2009 "Medical devices - Quality management systems - Requirements for regulatory purposes," (ISO 13485:2003)

Alternatively, device manufacturers may submit an audit report if their national regulatory body has adopted these standards and has conducted an audit of their facility.

"If, based on that report, FDA determines that there is minimal probability--in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved--that the establishment will produce nonconforming and/or defective finished devices, then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA's routine work plan for 1 year," said FDA.

Using authority granted to the agency under the FDA Amendments Act (FDAAA) of 2007, FDA's Centers for Devices and Radiological Health (CDRH) and Biologics Evaluation and Research (CBER) intend to launch the program 5 June 2010.


Read more:

Federal Register - Guidance for Industry, Third Parties and Staff; Availability: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program


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