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US FDA seeks input on incorporating new science in regulation

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is keen to incorporate “new science” into the regulatory decision-making process of its medical device unit and is inviting stakeholder feedback on how it should go about achieving this objective1. The agency says that new science may include novel technologies or novel uses of existing technologies, evolving information and knowledge, or new methods to support decision making.

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