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Home » ISO Guidance Now Slated for Release by Year-End

ISO Guidance Now Slated for Release by Year-End

October 24, 2008

The FDA’s planned guidance for devicemakers to voluntarily submit International Organization for Standards (ISO) audit reports has been delayed, but the agency now hopes to release it by the end of this year, according to a Center for Devices and Radiological Health (CDRH) GMP expert.

Devicemakers that submit ISO reports could avoid an agency inspection. “The thought right now is that we’re going to take them off the workload plan for at least a year because in at least somebody’s eyes that we have some confidence in has gone and looked at [the firm],” CDRH’s Kim Trautman said at the Parenteral Drug Association-FDA Joint Regulatory Conference.

The FDA Amendments Act, which reauthorized the Medical Device User Fee Act, allows the agency to take ISO audit reports into account when selecting which facilities to inspect. Timothy Ulatowski, director of CDRH’s Office of Compliance, had expected the guidance to be released in July.

Under the ISO plan, manufacturers can submit ISO 13485 reports from audits conducted by notified bodies to satisfy European, Canadian and Australian health regulatory requirements, Trautman said. The ISO report submissions would include company responses to observations.

CDRH is working with the Office of Regulatory Affairs and the Center for Biologics Evaluation and Research on the document, she said.

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