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Home » FDA slots five device types into class II, including for de novo granted in 2011
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FDA slots five device types into class II, including for de novo granted in 2011

Dec. 1, 2021
By Mark McCarty
The FDA’s device center is required to develop and publish special controls for devices that are deemed class II items via the de novo petition process, and five such declarations were posted Dec. 1 to the Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.
BioWorld MedTech Regulatory U.S. De novo FDA

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