The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical and Patient Decision Support Software.'' This draft guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for healthcare professionals, and patient decision support software intended for patients and caregivers who are not healthcare professionals. This draft guidance is not final nor is it in effect at this time.
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Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical and Patient Decision Support Software.'' This draft gui...
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82 FR 57987
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“Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (December 8, 2017), https://thefederalregister.org/documents/2017-26439/clinical-and-patient-decision-support-software-draft-guidance-for-industry-and-food-and-drug-administration-staff-availa.