Public Inspection: Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices From Food and Drug Administration (FDA) πΊπΈ Document number 2024-21575. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A draft guidance document by the FDA and industry on chemical analysis for assessing biocompatibility of medical devices, covering CMC and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on biocompatibility testing of medical devices for the ASCA Pilot Program. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 19, 2023 Other (Public Domain) 0 reuses 0 favorites
Notice on the Publication of Four Industry Standards, including "Preclinical Evaluation of Biocompatibility of Medical Devices for Oral Use Unit 1: Evaluation and Test Item Selection From National Medical Products Administration (NMPA) π¨π³ FGWJ-2001-10192 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on November 9, 2001 Other (Public Domain) 0 reuses 0 favorites