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Zdrowie i gospodarka · 08/12/2017

FDA Announces Draft Guidance on Medical Software Policies Resulting from 21st Century Cures Act

The FDA is releasing a draft guidance on changes to medical software policies due to the 21st Century Cures Act, aiming to clarify FDA's stance on the updated definition of a medical device and its impact on related guidances.

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