21 CFR Chapter I Subchapter H β Medical Devices β Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document by FDA and industry for evaluating thermal effects of medical devices that heat or cool tissues, focusing on safety and efficacy. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 14, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices From Food and Drug Administration (FDA) πΊπΈ A guidance document for preparing premarket notification applications for heating and cooling devices. 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on assessing radiofrequency-induced heating in the MR environment for medical devices. 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 February 9, 2019 Other (Public Domain) 0 reuses 0 favorites