FDA Releases Draft Guidance Documents on New Expedited Access Program for Premarket Approval of Medical Devices and Premarket and Postmarket Data Collection

On 23 April 2014, the Food and Drug Administration (FDA) released two related draft guidance documents related to premarket approval (PMA) applications for medical devices. The first outlines an expedited access PMA program, building off the pilot Innovation Pathway program. The second addresses the agency's plans for balancing premarket and postmarket data collection efforts. Both guidances are put forth by the agency as an effort to streamline FDA approval for devices addressing important medical needs.

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