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FDA Warns Manufacturers to Scrutinize Third-Party Testing Data

The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency.

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FCC Adopts Rules to Enable Consumers to Stop Robocalls, Robotexts

The U.S. Federal Communications Commission (FCC) has adopted new rules that give consumers more tools to fight back against unwanted robocalls and robotexts.

EU Commission Issues Regulations for Cybersecurity Certification Scheme (EUCC)

The EU Commission has published detailed regulations for the cybersecurity certification of certain products, taking the next step in implementing an EU-wide cybersecurity certification scheme.

FDA Amends Quality System Regulations for Medical Devices

The U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

Magnetic Field Conversions

This download provides a table of magnetic field conversion factors of microvolts-per meter, gauss, picotesla, microampere-per-meter, weber per-square meter, and gamma with values of either 0 db or 1 as a starting point.

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U.S. and EU Sign Joint Cybersafe Products Action Plan

The U.S. and the European Union have signed an agreement to work collaboratively to strengthen the cybersecurity of IoT-capable hardware and software products used by consumers.

FCC Makes AI-Generated Robocalls Illegal

In a landmark decision, the U.S. Federal Communications Commission (FCC) has unanimously ruled that robocalls made with voices generated by artificial intelligence (AI) tools are illegal.

EU Commission Proposes More Time for Compliance with IVDR

The EU Commission has proposed providing manufacturers of certain medical devices with additional time to comply with the requirements of the EU’s IVDR.

FCC Adopts Guidance on Orbital Space Debris

The FCC has recently published new guidance to provide further clarification around the requirements that apply to space satellite operators under the agency's existing orbital debris mitigation rules.

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