Joint EU-FDA Inspections Program Under Consideration

The FDA and the European Union (EU) are discussing a pilot program in which one auditor would conduct an inspection on behalf of both jurisdictions — an arrangement already under way between Health Canada and the FDA.

“We have this pilot program in Canada where it’s one auditor doing [International Standards Organization] and quality system audits at the same time,” Center for Devices and Radiological Health Director of Compliance Tim Ulatowski said during the recent Association for the Advancement of Medical Instrumentation/FDA International Conference on Medical Device Standards and Regulation. “We’ve had a number of successful audits right now that have occurred [and now] the EU wants to join in that pilot.”

Under the Pilot MultiPurpose Audit Program, a third-party auditor inspects a facility on behalf of the FDA and Health Canada. The FDA expects this to reduce inspection-related manufacturing interruptions and lower costs for devicemakers.

To facilitate such inspections, the FDA recently released a final Global Harmonization Task Force guidance on audit reports prepared on behalf of regulatory agencies.

The document, “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports,” is intended to promote uniformity and assist auditors in the preparation of reports that can be used by numerous regulators.