Zdrowie i gospodarka · 28/07/2017

Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program

The US Food and Drug Administration (FDA) is launching a Software Precertification Pilot Program to evaluate a new approach to software products, aiming to balance benefits and risks of digital health devices. The program will provide a voluntary precertification process for companies that design and test high-quality software.

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

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