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U.S. Food and Drug Administration (FDA)

FDA Names First Acting Director of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has appointed its first Active Director of...

FDA Sets Action Plan to Regulate AI in Medical Devices

The U.S. Food and Drug Administration (FDA) has released its plan for regulating certain...

FDA Launches Its Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help...

FDA Releases Guidance on EMC of Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical...

FDA Issues Guidance Documents on Pilot Accreditation Scheme

The U.S. Food and Drug Administration (FDA) has issued three final guidance documents in...
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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 Issues Guidance on ISO 10993-1 for Medical Device Biological Evaluation

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

FDA Issues Guidance on Recognition of Voluntary Consensus Standards

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

FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

FDA Issues Initial Guidance on Medical Device Regulatory Submissions in Electronic Format

The U.S. Food and Drug Administration (FDA) has issued initial guidance on its general...
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