Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands

 
• By David Filmore

A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.

three doors in a a row - red, yellow, green - yellow door open
• Source: Shutterstock

As more and more devices reach the US market through FDA's de novo pre-market pathway, the agency is formalizing its rules of the road for the approach that represents a middle-way between 510(k)s and PMAs.

The agency issued a proposed rule Dec. 4 that outlines requirements for the de novo classification process, including the proper format for submissions, the process for acceptance, reviews and...

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