FDA publishes Report on Third Party Audits of Medical Device Manufacturers

Ten medical devices manufacturers were audited by a "qualified audit organisation" within the context of a pilot programme. The idea was that a third "party" should audit the firms with regards to the requirements of the FDA and the Canadian health authority Health Canada at the same time. The goal was to save resources at the audited firms as well as at both authorities. The report published now ("

Final Joint Report of the Pilot Multipurpose Audit Program" - pMAP) summarises the findings of the pilot programme.

By performing one audit satisfying the regulatory requirements of two authorities, time savings of 25 to 58% were achieved with an average of 33% less total time spent. Interestingly, times spent increased in two cases. The reason behind this was a technical expert having been added in order to assess software validation aspects.

No nonconformities were issued in relation to regulations outside 21 CFR 820 or ISO 13485. The text assumes that this may have been due to the small sample size. It was apparent, furthermore, that the basis for the audits differed. Audits for Health Canada were a mix of surveillance audits and re-assessment audits while the audits performed for the FDA had a more supervisory character. In the future, this difference is to be adjusted.

It was also striking that several responses to nonconformities did not contain a cause analysis, a statement of correction, or a clear statement on the corrective actions to be taken to prevent recurrence of the nonconformity. These issues have already been identified in the past within the framework of audits by the FDA or by Health Canada. In future, different audit reports (scope, level of detail) are to be standardised by means of a form.

Conclusions: The results of the "Multipurpose Audit Program" are considered to be positive, also in respect of the savings of resources for industry as well as for both authorities.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA )

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