PMA/510(k) Expedited Review Guidance for Industry and Center for Devices and Radiological Health Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``PMA/510(k) Expedited Review Guidance for Industry and the Center for Devices and Radiological Health (CDRH) Staff.'' FDA believes it is in the interest of the public health to review premarket approval applications (PMA's) and premarket notifications (510(k)'s) for certain medical devices in an expedited manner. The expedited review will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives (preventive, diagnostic, or therapeutic) or when the new medical device promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities.