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FDA Announces eMDR Enhancements

The U.S. Food and Drug Administration (FDA) has posted a list of pending enhancements...

FDA Releases Final Guidance on Pre-Market Submissions for Med Device Software Functions

The U.S. Food and Drug Administration (FDA) has published a final version of its...

FDA Releases New Video on Cybersecurity in Healthcare Facilities

As part of its effort to protect healthcare workers and patients from equipment malfunction...

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...
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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...

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...
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