FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20 years, FDA has sought to implement and manage the De Novo review process by reference directly to the statutory language in the Federal Food, Drug, and Cosmetic Act (FDCA) and guidance documents.

FDA's new proposed rule, Medical Device De Novo Classification Process, (the De Novo proposed rule or the proposed rule) is the first time the agency has issued regulations to clarify the procedural and substantive requirements surrounding the De Novo premarket review pathway. Many of the provisions of the proposed rule are consistent with existing guidance, but a few new recommendations worth noting are discussed below.

Read More: FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?


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