federal_register: 2020-27248
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27248 | Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of three device-specific final guidance documents for the Safety and Performance Based Pathway--specifically, "Spinal Plating Systems--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff," "Orthopedic Non-Spinal Metallic Bone Screws and Washers-- Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff," and "Magnetic Resonance (MR) Receive-only Coil--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff." The device-specific guidances identified in this notice were developed in accordance with the final guidance entitled "Safety and Performance Based Pathway." | 2020-12-11 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/11/2020-27248/performance-criteria-for-safety-and-performance-based-pathway-guidances-for-industry-and-food-and | https://www.govinfo.gov/content/pkg/FR-2020-12-11/pdf/2020-27248.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 three device-specific final guidance documents for the Safety and Performance Based Pathway--specifically, "Spinal Plating Systems--Performance Criteria for Safety and... |