Regulatory Experts Note Wrinkles In FDA Accepting ISO 13485 Quality Audits
Why are FDA insiders skeptical about the idea of having a resource-starved FDA use internationally-accepted ISO 13485 audit reports in place of its own foreign facility inspections?
This article preview is reprinted from "The Gray Sheet" - June 2 2008
The idea of having a resource-starved FDA use internationally-accepted ISO 13485 audit reports in place of its own foreign facility inspections is gaining traction in Washington.
But FDA insiders, while not dismissing the idea, note that it is fraught with complications.
The FDA Amendments Act of 2007 directs FDA, for the purpose of setting risk-based inspection priorities, to accept voluntary submissions of International Organization of Standardization (ISO) quality system audit reports.
Device industry lobbyists now say FDA should go a step further.
At a recent hearing of the House Energy and Commerce health subcommittee, AdvaMed President Steve Ubl urged Congress to amend the law to allow FDA to accept the ISO 13485 international quality system standard as equivalent to the agency's own Quality System Regulation (QSR) (1"The Gray Sheet" May 19, 2008, p. 4).
"Doing so would allow FDA to use a company's compliance with the ISO standards in place of an FDA inspection," Ubl said. "This also would bring FDA into harmonization with the internationally recognized and accepted quality systems."
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