federal_register: 2023-27852
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-27852 | Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." FDA is issuing this draft guidance to clarify how FDA evaluates real- world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance proposes expanded recommendations to the 2017 guidance entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." This draft guidance is not final nor is it for implementation at this time. | 2023-12-19 | 2023 | 12 | https://www.federalregister.gov/documents/2023/12/19/2023-27852/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-draft-guidance | https://www.govinfo.gov/content/pkg/FR-2023-12-19/pdf/2023-27852.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." FDA is issuing this draft guidance to clarify how FDA... |