federal_register: 2019-21001

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2019-21001 Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act." This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software. 2019-09-27 2019 9 https://www.federalregister.gov/documents/2019/09/27/2019-21001/changes-to-existing-medical-software-policies-resulting-from-section-3060-of-the-21st-century-cures https://www.govinfo.gov/content/pkg/FR-2019-09-27/pdf/2019-21001.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act." This guidance provides clarity on...  

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