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Standards and Compliance

Antenna Selection for IEC 61000-4-3

With so many different antenna options on the market, it is not always easy to understand what will work best for your application.

U.S. FDA Issues Guidance on Medical Devices Containing Materials of Animal Origin

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

FDA Issues Guidance on Device Exemptions from Pre-Market Notification Requirements

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

U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...

Update on CCC Certification Scheme for Automotive Parts

Chinese Certification Authorities to Announce Important Changes in the CCC Certification Scheme for Automotive...
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A Look at the European Commission’s New Low Voltage Directive Guide

The European Commission's Low Voltage Directory (LVD) legal obligations vary for economic operators, with most falling upon manufacturers. The new LVD Guide offers interpretation and instruction on these obligations, clarifying when importers and distributors might take on manufacturer responsibilities among other issues.

Brexit and Its Impact on Market Access

This article provides an analysis of the steps that manufacturers and distributors can take now to help ensure their continued access to the markets in the 27 remaining European Union Member States (EU-27) following the exit of the United Kingdom on 30 March 2019.

Upcoming Changes to UN 38.3 Lithium Battery Testing

This article provides information on the changes found in Amendment 1 to the 6th Edition of UN 38.3, which details recommended testing to assess potential hazards associated with lithium-ion batteries in transit.

FDA Proposes Improvements in De Novo Pathway for Medical Devices

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

FDA Issues Final Guidance on Manufacturing Site Changes

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