A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.
The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH received and granted in 2017 and 2018, with the exception of one 2009 submission that was not granted until 2012.
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