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Zdrowie i gospodarka · 21/10/2022

FDA Announces Draft Guidance for Breakthrough Devices Program to Address Health Disparities

The Food and Drug Administration (FDA) has released a draft guidance document outlining updates to the Breakthrough Devices Program, aiming to reduce disparities in health and healthcare by clarifying its application to medical devices treating life-threatening conditions in underserved populations.

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