Pilot Program for ISO 13485 Audits Sounds Promising

Mark Crawford

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

Starting June 5, 2012, the FDA will launch a voluntary pilot program that allows device manufacturers that have been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) using the 13485:2003 standard to voluntarily submit those results to the FDA to be considered for a possible one-year bye from FDA inspection.

“If, based on that report,” the guidance states, “FDA’s analysis or compliance decision meets the requirements of the FDA’s Medical Device Compliance Program 7382.845 for “Situation II,” 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 inspection work planfor one year from the last day of the ISO 13485:2003 audit.”

If FDA reviewers accept a manufacturer’s most recent ISO 13485 audit report, that company is exempted from FDA quality system inspection for one year from the date of its most recent ISO 13485 audit.

“The world is using 13485 and many quality-management systems audits are being performed by other regulators and third-party authorized auditing bodies,” says Kim Trautman, associate director for international affairs for the Center for Devices and Radiological Health. “The FDA wants to explore how we can leverage off some of these other audits and utilize some of the trusted partners’ work in auditing manufacturers.”

 The program is only available to manufacturers that have already registered their devices for sale in the U.S.and established FDA GMP-compliant quality systems. Furthermore, qualifying manufacturers must also have ISO 13485 certification in place prior to participation in the program.

Manufacturers should make arrangements with their regulatory third-party auditors prior to the scheduled audit to ensure that the audit and its report will be eligible for the pilot program. The FDA will consider for eligibility under this pilot program ISO 13485:2003 audit reports sent to the FDA within 90 days from the last day of the most recent audit. Reports can be either a full assessment of the establishment’s Quality Management System (QMS) or a surveillance audit of the establishment’s QMS.

“We will use ISO 13485 as a risk-based process for planning and using FDA resources and inspection resources wisely,” adds Trautman. “We are very excited to launch this new program and hope that manufacturers take this opportunity. FDA wants to use this experience to help further develop a medical device single-audit program. We’re excited to possibly use information that’s already available to help us optimize the use of FDA resources and really put those resources toward the places that need the most attention.”

The agency has launched an online video, slide presentation and transcript covering key aspects of the program. See the original guidance at:


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