FDA classifies slew of class II devices following de novo procedures

FDA classifies slew of class II devices following de novo procedures

Submitted by admin on January 4, 2023 - 5:24pm
Source: 
RAPS.org
News Tags: 
FDA
devices
Medtech
SaMD
de novo pathway
Headline: 
FDA classifies slew of class II devices following de novo procedures
snippet: 

Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with special controls. The list of devices includes several software as a medical device (SaMD) products.

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