CDRH recently announced the completion of a pilot program with Health Canada (HC) to perform joint inspections.
The pilot inspected 10 companies, who volunteered for the program. The inspectors were in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices conformity Assessment System (CMDCAS). One of the pilot project’s goals was to determine the potential for time savings in the inspection process. This would benefit FDA, HC, and the site under investigation. The pilot showed savings of about 35% in person-days to conduct the inspection.
The final joint report, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm232806.htm, describes the results of the project.
The final report lists findings and recommendations. We describe a few of them below.
The activity types should align. The activity should pair HC surveillance with FDA Level 1; pair HC re-assessment and FDA Level 2.
Nonconformity responses didn’t contain a cause analysis, a clear statement of the correction, or a clear statement of the corrective action. As a result, both HC and FDA intend to train inspectors using the Global Harmonization Task Force guidance GHTF/SG3/N18 “Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes”. See www.ghtf.org.
Reports varied in description, level of detail, and format. They varied in length from 3 to 20 pages. FDA and HC are collaborating on a single report format developed in HC “GD 211: Guidance on the content of quality management system audit reports”.