Zdrowie i gospodarka · 23/04/2014

FDA Announces Expedited Access Program for Life-Threatening Medical Devices

The FDA has released a draft guidance outlining a new voluntary program to expedite the development and review of medical devices addressing unmet needs for life-threatening or debilitating conditions, aiming to improve patient access while maintaining safety and effectiveness standards.

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

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