federal_register: 2016-24805
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-24805 | Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Software as a Medical Device (SaMD): Clinical Evaluation." The draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The draft guidance pertains to the conduct of clinical evaluation of Software as a Medical Device (SaMD) and focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD. This draft guidance is not final nor is it in effect at this time. | 2016-10-14 | 2016 | 10 | https://www.federalregister.gov/documents/2016/10/14/2016-24805/software-as-a-medical-device-clinical-evaluation-international-medical-device-regulators-forum-draft | https://www.govinfo.gov/content/pkg/FR-2016-10-14/pdf/2016-24805.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Software as a Medical Device (SaMD): Clinical Evaluation." The draft guidance was prepared under the auspices of the International Medical... |