federal_register: 2019-21000
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-21000 | Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Clinical Decision Support Software." This guidance clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). This guidance describes a risk-based approach for regulatory oversight of CDS software functions that remain devices using the categories defined by the International Medical Device Regulators Forum (IMDRF) final document entitled "Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations." The guidance also provides clarity on the types of CDS software functions on which FDA intends to focus its regulatory oversight for health care providers, patients, and caregivers. This draft guidance is not final nor is it in effect at this time. | 2019-09-27 | 2019 | 9 | https://www.federalregister.gov/documents/2019/09/27/2019-21000/clinical-decision-support-software-draft-guidance-for-industry-and-food-and-drug-administration | https://www.govinfo.gov/content/pkg/FR-2019-09-27/pdf/2019-21000.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Clinical Decision Support Software." This guidance clarifies the types of clinical decision support (CDS) functions that do not meet the... |