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Zdrowie i gospodarka · 13/04/2015

FDA Announces Expedited Access Program for Life-Threatening Medical Devices

The FDA is releasing a new guidance document outlining a voluntary program to expedite the development and review of medical devices addressing unmet needs for life-threatening or debilitating diseases, with the goal of improving patient access while maintaining safety and effectiveness standards.

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