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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.

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

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...

The partial shutdown of many federal agencies has apparently not stopped the U.S. Food...

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The U.S. Food and Drug Administration (FDA) has now provided access to presentations from...

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

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

The U.S. Food and Drug Administration (FDA) has published a final rule that brings...

The U.S. Food and Drug Administration (FDA) has issued an updated Guidance on its...

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