21 CFR Chapter I Subchapter H โ Medical Devices โ Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 878 General and Plastic Surgery Devices". 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 on June 4, 2024 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Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Draft guidance document by FDA and industry for evaluating thermal effects of medical devices that heat or cool tissues, focusing on safety and efficacy.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) ๐บ๐ธ 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
Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2016-02878. The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part ofโฆ Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on February 12, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2011-2552. The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Specialโฆ Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on February 7, 2011 Other (Public Domain) 0 reuses 0 favorites
Notice on the definition of the classification of medical physical cooling apparatus and other products From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2006-10045 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 August 31, 2006 Other (Public Domain) 0 reuses 0 favorites