EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the Food Drug & Cosmetic Act, and when the sponsor has determined that the device does not fall within any existing classification regulation.
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