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Home » Notable FDA Regulatory Actions in 2022 Feature QMSR, Cybersecurity
Notable FDA Regulatory Actions in 2022 Feature QMSR, Cybersecurity
The Center for Devices and Radiological Health (CDRH) issued 39 final guidances in 2022, nearly doubling the 21 issued the previous year, but it was a Feb. 23 draft rule that garnered the most attention — Medical Devices; Quality System Regulation Amendments — that proposes to align the 20-year-old FDA quality system requirements (QSR) with International Organization for Standardization (ISO) requirements.