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U.S. Food and Drug Administration (FDA)

FDA Updates Consumer Information on OTC Hearing Aids

In a separate development, the U.S. Food and Drug Administration (FDA) has also updated...

FDA Releases Latest Third-Party Review Performance Report

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

FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new...

FDA Posts Updated FAQs on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released an updated list of frequently...

Biotech Company to Pay $12 Million for False Compliance Claims

A manufacturer of cochlear implants has agreed to pay a major financial penalty for...
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FDA Releases ASCA Annual Report for 2022

The U.S. Food and Drug Administration (FDA) has released its annual report on its...

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...

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to...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