FDA to release ISO audit guidance for medical devicemakers

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The FDA will release a draft guidance this month on how it will interpret international organization for standardization (ISO) audit reports when determining its inspection priorities for medical devicemakers.

Under the FDA Amendments Act, which reauthorized the Medical Device User Fee Act, the agency is authorized to take ISO audit reports into account when selecting which facilities to inspect, according to FDA News. Manufacturers would voluntarily submit the reports to the agency.

“I’m going to be very positive about [ISO audit reports] in regards to who we are going to inspect and so direct our districts,” said Timothy Ulatowski, director of the Center for Devices and Radiological Health’s Office of Compliance.

The audit reports can be used by medical devicemakers “to indicate to FDA that [the company has] had a satisfactory ISO audit,” Ulatowski said.

He also mentioned a planned guidance on good importer practices that would advise the industry on what the agency expects from firms regarding importer practices, which may lead to more or less attention “in regards to inspections…depending on the application of those practices by industry,” Ulatowski said.