Zdrowie i gospodarka · 11/10/2005
Medical Devices: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff." The revised guidance extends the voluntary pilot premarket review program Summary Technical Documentation (STED pilot) until we have received an adequate number of submissions to evaluate the STED pilot. The pilot program is intended for evaluating the utility of an alternative submission procedure.