federal_register: 2019-20370
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2019-20370 | Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathway--specifically, "Spinal Plating Systems--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; "Cutaneous Electrode for Recording Purposes--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; "Conventional Foley Catheters--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; and "Orthopedic Non-Spinal Metallic Bone Screws and Washers-- Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff." The device-specific draft guidances identified in this notice were developed in accordance with the finalized guidance entitled "Safety and Performance Based Pathway." These draft guidances are not final nor are they in effect at this time. | 2019-09-20 | 2019 | 9 | https://www.federalregister.gov/documents/2019/09/20/2019-20370/safety-and-performance-based-pathway-device-specific-guidance-draft-guidances-for-industry-and-food | https://www.govinfo.gov/content/pkg/FR-2019-09-20/pdf/2019-20370.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| 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathway--specifically, "Spinal Plating Systems--Performance Criteria for Safety and... |