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Zdrowie i gospodarka · 13/04/2015

FDA Releases Guidance on Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

The Food and Drug Administration (FDA) has announced the availability of a new guidance document that clarifies its policy on balancing premarket and postmarket data collection for medical devices subject to premarket approval, aiming to improve patient access to safe and effective devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →