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FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

FDA Issues Initial Guidance on Medical Device Regulatory Submissions in Electronic Format

The U.S. Food and Drug Administration (FDA) has issued initial guidance on its general...

U.S. FDA Issued Guidance on Enforcement of Non-Invasive Remote Monitoring Devices

As the impact of the COVID-19 pandemic continues to challenge the nation’s healthcare system,...

Radio Amateurs’ Ventilator Design Goes to FDA

A low-cost ventilator design developed with the assistance of radio amateurs will soon be...

U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...
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U.S. FDA Allows Expanded Use of Medical Devices for Remote Patient Monitoring

In an action to support the healthcare system care for patients during the COVID-19...

U.S. FDA Takes Steps to Ban Electroshock Therapy Devices

The U.S. Food and Drug Administration (FDA) has taken steps to end the use...

U.S. FDA Releases Literature Review of Radiofrequency Radiation and Cancer

The U.S. Food and Drug Administration (FDA) has released a comprehensive report summarizing the results of...

FDA Updates Database of Recognized Consensus Standards for Medical Devices

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

Robotic Medical Device Recalled Due to Software Issue

A major medical device manufacturer has recalled a robotic medical surgical device due to...
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