FDA BRIEF: Week of July 11, 2016
Neurological Devices: Classification of Thermal System for Insomnia
Product : Cereve Sleep System
Classification: Class II special controls.
Codification: 21 CFR 882.5700
Risks and Mitigations:
Table 1--Thermal System for Insomnia Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation method ------------------------------------------------------------------------ Adverse skin reaction.................. Biocompatibility Assessment. Labeling. Electromagnetic Interference with Other Electromagnetic Compatibility Devices. Testing. Labeling. Electrical Safety (e.g., shock)........ Electrical Safety Testing. Labeling. Thermal Injury......................... Non-clinical Performance Testing. Software Verification, Validation, and Hazard Analysis. Labeling. ------------------------------------------------------------------------
Gastroenterology-Urology Devices: Metallic Biliary Stent System for Benign Strictures
Product : WallFlex Biliary Rx Fully Covered Stent System
Classification: Class II special controls.
Codification: 21 CFR 876.5011
Risks and Mitigations:
Table 1--Metallic Biliary Stent System for Benign Strictures Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility Evaluation. Labeling. Infection.............................. Sterilization Validation. Shelf Life Validation. Labeling. Bile duct obstruction.................. Clinical Performance Testing. Stent migration...................... Non-clinical Performance Testing. Stent does not resolve obstruction... Shelf Life Validation. Stent cannot be placed............... Labeling. Expansion/compression forces. Foreshortening....................... Trauma to bile ducts................... Clinical Performance Testing. [[Page 45231]] During stent deployment.............. Non-clinical Performance Testing. During removal....................... Shelf Life Validation. Due to stent migration............... Labeling. During stent indwell. Inability to safely remove stent..... Expansion/compression forces......... ------------------------------------------------------------------------