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FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections

3 weeks 6 days ago

On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850).

The post FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections appeared first on MedTech Intelligence.

Rich West

The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

3 weeks 6 days ago

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.

The post The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices appeared first on MedTech Intelligence.

Rich West