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Business · 06/08/2013Updated: 10/17/2026 · 1 min read

FDA Modernization Act of 1997: Updates to Recognized Standards for Medical Devices

Summary

The Food and Drug Administration (FDA) is updating its list of recognized standards for premarket reviews, adding new standards related to medical device interoperability. This change aims to help manufacturers comply with requirements for medical devices by declaring conformity with consensus standards.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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