Devices

Town Hall Discusses QMSR Basics and Answers Questions

David McFarland

— 1 min read
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A 4/1 CDRH Town Hall reviewed the new Quality Management System Regulation (QSMR) and its associated Compliance Program for medical device risk-based inspections. Office of Medical Devices and Radiological Health Inspectorate senior advisor Karen Masley-Joseph described the QMSR program that became effective 2/2. She said the new Compliance Program number is 7382.850 and can be found on the FDA Web site by searching for FDA Compliance Program Manual.

Starting at the most basic place, Masley-Joseph said there are two parts to FDA’s inspections of medical device manufacturers — (1) to evaluate if the manufacturer’s quality management system (QMS) meets agency requirements and provides reasonable assurance that devices will be safe and effective, and (2) to evaluate if the manufacturer’s risk management and risk-based decision-making are effectively used in the QMS.

She went into significant detail on the inspection process, stressing that it is flexible in that the QMS areas and Other Applicable FDA Requirements do not need to be evaluated in a specific order.

Following Masley-Joseph’s detailed presentation, a panel of CDRH experts responded to frequently asked questions, making these points:

  • manufacturers must document their risk management processes and demonstrate how they apply risk-based approaches throughout their QMS;
  • manufacturers can use different risk management approaches for different parts of their QMS as long as the approaches are appropriate for the specific risks involved;
  • the specific documents and evidence investigators will review depend on the risks associated with the manufacturer’s device and the inspection priorities;
  • investigators are no longer following the agency’s medical device single audit program approach for QMSR inspections;
  • investigators will conduct records reviews and not just a sampling of records;
  • all medical device inspections on or after 2/2 will follow the QMSR requirements;
  • FDA does not expect that manufacturer records created before 2/2 will be revised to meet QMSR requirements;
  • the risk-based approach applies to all QMS activities, including so-called administrative processes;
  • the threshold for FDA taking compliance action has not changed with QMSR; and
  • the best way to prepare for a QMSR inspection is to meet the FDA requirements that apply to the FDA-regulated product.

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