FDA Plans to Release ISO Audit Guidance Shortly

The FDA will release a draft guidance this month on how it will interpret International Organization for Standardization (ISO) audit reports when determining its inspection priorities for devicemakers, an agency director says.

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. 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,” Timothy Ulatowski, director of the Center for Devices and Radiological Health’s Office of Compliance, said at the FDAnews Fifth Annual Medical Device Quality Congress in Cambridge, Mass.

The audit reports can be used by devicemakers “to indicate to FDA that [the company has] had a satisfactory ISO audit. ‘FDA go somewhere else. We’ve been seen by an auditor,’” Ulatowski said.

He also mentioned a planned guidance on good importer practices, which FDA Commissioner Andrew von Eschenbach told lawmakers the agency was planning during a House Oversight and Investigations Subcommittee hearing in April on the agency’s inspection program and the highly publicized heparin contamination.

That guidance would advise 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.