The FDA has issued a final rule aimed at simplifying the de novo classification process for medical devices.
In publishing the final rule yesterday, the FDA established procedures and criteria for submitting and withdrawing a de novo request while also setting guidelines for the FDA to decide on such a request. The changes matter because de novo allows some medical devices to leapfrog the premarket approval process.
FDA said that, while several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule aimed at establishing regulations for the process.
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