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FDA implements QMSR: Medical device inspections to be conducted under an updated process

On February 2, 2026, the FDA will begin implementing the Quality Management System Regulation (QMSR), which amends the Quality System Regulation (21 CFR Part 820). The FDA will discontinue use of the Quality System Inspection Technique (QSIT) for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). As of February 2, 2026, the FDA will no longer use Inspection of Medical Device Manufacturers (CP 7382.845) or Medical Device PMA Preapproval and PMA Postmarket Inspections (CP 7383.001).

This action is part of implementing the amendments to 21 CFR Part 820, the Quality Management System Regulation. The action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

Additional Resources:

• Quality Management System Regulation – Frequently Asked Questions

Questions?

If you have questions, contact the Division of Industry and Consumer Education.