U.S. Food and Drug Administration (FDA)

In an effort to keep pace with its oversight of advanced medical devices and...

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

As part of its effort to evaluate its precertification framework for software with medical...

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The U.S. Food and Drug Administration (FDA) has issued a guidance to clarify the...

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

The FDA has issued an updated version of its guidance on premarket approval (PMA) application submissions and reviews for medical devices.

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