federal_register: 2022-20993

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2022-20993 Clinical Decision Support Software; 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 "Clinical Decision Support Software." This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). 2022-09-28 2022 9 https://www.federalregister.gov/documents/2022/09/28/2022-20993/clinical-decision-support-software-guidance-for-industry-and-food-and-drug-administration-staff https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-20993.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 "Clinical Decision Support Software." This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software...  

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