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  • Changes Coming to Medical Device Pre-submission Meeting Program

    The US Food and Drug Administration (FDA) has released new draft guidance for medical device manufacturers looking to meet with the agency in advance of submitting a wide range of device applications. Once finalized, the guidance-which formerly only covered Investigational Device Exemption (IDE) applications-will include 510(k) premarket notification applications, premarket approval (PMA) applications and Humanitarian Device Exemption (HDE) applications. FDA explaine...