Faster FDA Approval for Medical Devices Coming Soon
In April the U.S. Food and Drug Administration released two draft guidance documents related to premarket approval applications for medical devices. The first outlined an Expedited Access PMA program, building off the earlier pilot Innovation Pathway program. The second addressed the FDA's plans for balancing premarket and postmarket data collection efforts. Both forms of guidance represent an effort by the agency to expedite FDA approval for devices addressing important medical needs.