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FDA Struggles to Meet Product Review Deadlines

Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.

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FDA Warns Against Unauthorized Modifications to Medical Devices

The U.S. Food and Drug Administration (FDA) is also stepping up its efforts to identify FDA-cleared medical devices that have been subsequently modified and that no longer fall within the scope of their original clearance.

FDA Alerts the Medical Device Industry About Unreliable Third-Party Test Data

The U.S. Food and Drug Administration (FDA) is advising medical device manufacturers to take steps to verify the accuracy and reliability of third-party testing data before submitting it to the FDA.

FCC to Investigate CCP-Aligned Entities

The U.S. Federal Communications Commission (FCC) has launched a major investigation into entities operating in the U.S. that are aligned with China’s Communist Party (CCP) and whose communications equipment has been placed on the FCC’s Covered List.

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Compliance Resources

Use of a PC-Based Digitizer in Medical Acoustic Microscopy System

Advancing medical acoustic microscopy through innovative digital techniques: maximizing echo detection, enabling high-speed scanning, and achieving precise, synchronized ultrasonic imaging.

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NIST Releases Draft of Quick Start Guide for Cybersecurity Framework 2.0

The U.S. National Institute of Standards and Technology (NIST) has released for public comment a draft of a Quick Start Guide for its Cybersecurity Framework 2.0.

Was it the Radar? Respectfully Revisiting the 1967 US Navy USS Forrestal Carrier Disaster: Part 2

How can the EMI/EMC community continue to blame this accident on electromagnetic interference (EMI) from the USS Forrestal’s on-board AN-SPS-43 search radar when the official US Navy inquiry comes to different conclusions?

EU Commission Releases Its Consumer Conditions Scoreboard

The Commission of the European Union (EU) has published its biennial report monitoring consumer sentiment across the EU in connection with consumer conditions in the Union.

Achieving and Sustaining Medical Device Compliance

Change is the only constant. A product lifecycle approach underpinned by a proactive and reactive regulatory and compliance strategy is key to success. Using digital tools to augment that process generates faster yet reliable data and results to bring safer medical devices to market that improve patient outcomes.

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Feature Articles

Filter Designs for Switched Power Converters: Part 2

This series of articles delves into the design principles of power filters for switched-mode power converters and similar applications, focusing on conducted and radiated emissions. Part 2 will examine specific aspects of switched power converters.

Tailoring MIL-STD-461 RE102

This article describes the parameters that can be used to tailor your application of MIL-STD-461 RE102, such as frequency ranges, designing notches, and relaxing limits.

A Circuit Model for the Charged Device Model Spark

The charged device model spark itself is not just resistive; it often has extra inductance or L-C energy storage. These plus hardware properties affect the CDM waveform and affect methods to correlate alternate CDM test methods to standard JEDEC CDM.

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