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FDA Updates Draft Recommendations for 510(k) Device Modifications

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...

U.S. Marketing Authorization of Novel Medical Devices

Common FDA Regulatory Pathways for Uncommon Devices

FDA Proposes Ban on Electrical Stimulation Devices for Behavioral Conditioning

The U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation...

FDA Approves Motorized Leg Braces

The U.S. Food and Drug Administration (FDA) has approved a medical device that functions...
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FDA Approves “Smart” Contact Lens Medical Device

The U.S. Food and Drug Administration (FDA) has approved the marketing of a one-time...

St. Jude Medical Device Recall Gets FDA Class 1 Status

The U.S. Food and Drug Administration (FDA) has reclassified as a Class 1 Advisory...

FDA Identifies Priority Medical Devices for Human Factors Review

The U.S. Food and Drug Administration (FDA) is soon likely to require human factors...

FDA Issues Guidance on Medical Device Cybersecurity

As part of it overall effort to ensure the safety of patients, the U.S....

FDA Reopens Public Comment on Hearing Aid Guidance

The U.S. Food and Drug Administration (FDA) has reopened a public comment period on...
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