FDAnews Device Daily Bulletin

ISO Guidance Now Slated for Release by Year-End

Oct. 10, 2008
The FDA’s planned guidance for devicemakers to voluntarily submit International Organization for Standards (ISO) audit reports has been delayed, but the agency hopes to release it by the end of this year, according to CDRH’s GMP expert Kim Trautman. Devicemakers that submit ISO reports could avoid an agency inspection. The FDA Amendments Act allows the agency to take ISO audit reports into account when selecting which facilities to inspect. 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.