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US FDA Classifies 5 De Novo-Cleared Device Types

 
• By Elizabeth Orr

The five products include a conditioning tool for eating disorders, a system that evaluates the properties of esophogeal tissue, and a tool used to measure the strain on an orthopedic implant during surgery.

Vintage wooden library card catalog with one drawer open.
• Source: Alamy

Five devices that initially reached market via the de novo review pathway will be regulated as moderate-risk class II, the US Food and Drug Administration announced on 1 December. The affected devices cross a range of sectors, including neurological, orthopedic and anesthesiology products.

The de novo pathway was developed as an alternative to the PMA and 510(k) regulatory tracks for products that aren’t...

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