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FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

FDA Issues Guidance on ISO 10993-1 for Medical Device Biological Evaluation

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the...

FDA Issues Guidance on Recognition of Voluntary Consensus Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance on how the...

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...
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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...

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...
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