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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...

FDA Issues Draft Guidance on Safety of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has issued a draft guidance on assessing...
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FDA Releases Guidance on Diagnostic Ultrasound Systems

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

U.S. FDA Seeks Test Cases for Digital Health Software Precertification

As part of its effort to evaluate its precertification framework for software with medical...

FDA Issues Guidance on Laser Products

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

FDA Issues Guidance on Medical X-Ray Devices and Conformity with IEC Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...

FDA Issues Guidance on Premarket Submission Info on Performance Testing

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to...
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