Day

October 26, 2014
26
Oct

FDA De Novo Summaries and Submissions

October 26, 2014
FDA CDRH maintains a webpage for De Novo Summaries: Evaluation of Automatic Class III Designation De Novo Summaries. This is for devices that are novel but low to moderate risk ((not ideal for 510(k)s and PMA would be overly burdensome). There are now two options for de novo classification. One is in response to an...
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