Medical Devices

In a major development for medical device manufacturers, the Parliament and Council of the European...

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards...

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...

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

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

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