Zdrowie i gospodarka · 21.07.1998
New Model Medical Device Development Process; Availability
The Food and Drug Administration FDA is announcing the availability of a document entitled ``New Model Medical Device Development Process.'' In this document, FDA outlines a new model for the investigational device exemption (IDE) and premarket approval application (PMA) development and review process. FDA is issuing this document as part of its commitment to improve the IDE and PMA development and review process.