The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.'' This draft guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the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. This draft guidance is not final nor is it in effect at this time.
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Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Changes to Existing Medical Software Policies Resulting from Sec...
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82 FR 57991
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“Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (December 8, 2017), https://thefederalregister.org/documents/2017-26442/changes-to-existing-medical-software-policies-resulting-from-section-3060-of-the-21st-century-cures-act-draft-guidance-f.