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FDA Releases Third-Party Review Performance Report

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

FDA to Host Webinar on In Vitro Diagnostic Devices EMC

The U.S. Food and Drug Administration (FDA) will host a webinar in early February...

Wi-Fi Could Help Identify Breathing Issues

Difficulty in breathing is one of many important warning signs of a pending medical...

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to...

FDA Clarifies Definition of “Device”

The U.S. Food and Drug Administration (FDA) recently issued a guidance document to clarify...
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FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...

FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug...

FDA Updates Recognized Standards List

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

FDA to Authorize Non-Prescription Hearing Aids

In a milestone development, the U.S. Food and Drug Administration (FDA) will soon authorize...

FDA Issues Updated Guidance on Medical Device UDI Requirements

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