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medical devices

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...

EU Commission Releases Report on Notified Body Response to Medical Device Conformity Assessments During Pandemic

The Commission of the European Union (EU) has published the results of its survey...

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,...

U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...
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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...

Creating A Smart Insulin Patch The Size Of A Coin

UCLA researchers are making strides to create a smart patch capable of delivering insulin to patients directly through their skin.

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...

EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...
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