federal_register: 2021-07860

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2021-07860 Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act Rule The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act. 2021-04-19 2021 4 https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions https://www.govinfo.gov/content/pkg/FR-2021-04-19/pdf/2021-07860.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the...

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