Zdrowie i gospodarka · 14/11/2013

Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Device Development Tools." This document provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. This draft guidance is not final nor is it in effect at this time.