FDA releases new case study about its pre-submission program

The FDA announced the it has published a new case study that illustrates how innovators can seek feedback from the agency through its pre-submission program. The case is part of the National Medical Device Curriculum, which seeks to provide innovators with FDA-endorsed knowledge on navigating its regulatory processes for medical devices. It includes topics related to the design of devices, their nonclinical and clinical premarket testing, and identification of adverse events.

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