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CDRH Updates - March/April 2017

·         Presentation (WMV - 11.4MB)

·         Printable Slides (PDF - 273KB)

·         Transcript (PDF - 155KB)

§  Presentation (WMV - 19.5MB)

§  Printable Slides (PDF - 937KB)

§  Transcript (PDF - 274KB)

§  Case Study: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device (PDF - 504KB)

 

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class II devices that, when finalized, will be  exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment. Submit either electronic or written comments on the notice by May 15, 2017. 

 

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class I devices that are now exempt from premarket  notification requirements, subject to certain limitations. FDA is  publishing this notice of that determination in accordance with  procedures established by the 21st Century Cures Act.
 
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