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U.S. Food and Drug Administration (FDA)

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...

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...
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Robotic Medical Device Recalled Due to Software Issue

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

FDA Recalls Insulin Pump Due to Cybersecurity Risk

Medtronic has issued a recall of the company’s MiniMed model insulin pump due to...

FDA Proposes Updates to List of Class II Exempt Devices

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of...

FDA Sets Policy for Device Functions of Mobile Medical Apps

In an effort to keep pace with its oversight of advanced medical devices and...

FDA Releases Guidances on Benefit-Risk Determinations for Medical Devices

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related...
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