The FDA is looking to roll out two policies “intended to expedite access to potentially life-saving devices meant for patients with life-threatening or serious conditions.” The first draft guidance document establishes pathways for the review and expedited approval “for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions.” The second draft guidance establishes parameters in which post-approval studies can be used to offset some pre-approval study requirements of certain devices.
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