CPC Comments on FDA’s “Medical Devices; Quality System Regulation Amendments”

On May 24, 2022, the CPC submitted a comment letter to FDA regarding the agency’s proposed rule regarding “Medical Devices; Quality System Regulation Amendments.” CPC greatly appreciates FDA’s efforts to harmonize good manufacturing requirements of the Quality System Regulation with the International Organization for Standardization’s consensus standard for devices, CPC’s comments highlight certain areas where CPC seeks additional clarity from FDA.