medical devices

FDA Updates List of Recognized Standards

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

FDA Issues Guidance on Qualification of Medical Device Development Tools

The U.S. Food and Drug Administration (FDA) has published its final Guidance on the...

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...
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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...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its...

FDA Posts Updated FAQs on Medical Device Cybersecurity

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

FDA Releases Third-Party Review Performance Report

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

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for...
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