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premarket

FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform...

FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

FDA Updates Database of Recognized Consensus Standards for Medical Devices

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

FDA Proposes Updates to List of Class II Exempt Devices

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of...

FDA Releases Guidances on Benefit-Risk Determinations for Medical Devices

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related...
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FDA Releases Guidance on Diagnostic Ultrasound Systems

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

FDA Issues Guidance on Premarket Submission Info on Performance Testing

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

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