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Evaluation of Automatic Class III Designation (De Novo) Summaries (K100934 added)
Scritto da CDRH New   
RadiodiagnosticaThe Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III ... ...
 
Federal Register: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To
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RadiodiagnosticaThe FDA is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is ... ...
 
Class I Medical Device Recall: Covidien, Puritan Bennett 840 Series Ventilator - Software Problem
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RadiodiagnosticaDue to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used o ... ...
 
Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 letter added)
Scritto da CDRH New   
RadiodiagnosticaThe Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a &am ... ...
 
FDA Voice Blog: Setting the Bar for Blood Glucose Meter Performance
Scritto da CDRH New   
RadiodiagnosticaFDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public. ... ...
 
PMA Final Decisions for September 2013
Scritto da CDRH New   
RadiodiagnosticaThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2013. ... ...
 
PMA Final Decisions for October 2013
Scritto da CDRH New   
RadiodiagnosticaThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2013. ... ...
 
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