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FDA Clarifies Definition of “Device”

The U.S. Food and Drug Administration (FDA) recently issued a guidance document to clarify...

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...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...
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FDA Issues Updated Guidance on Medical Device UDI Requirements

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

FDA Launches New Premarket Submissions Tracker

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

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...

FDA Expands Efforts to Accredit Testing Laboratories Under ASCA Pilot Program

The U.S. Food and Drug Administration (FDA) is ramping up its efforts to expand...

FDA Updates List of Recognized Standards

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