Medical Devices

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

FDA Adds Vaporized Hydrogen Peroxide as Established Sterilization Method for Medical Devices

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.

MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a...

FDA Issues Guidance on Electronic Submissions of 510(k)s

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket...

FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its...

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FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity...

FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

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

FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

FDA Updates List of Recognized Standards

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

FDA Issues Guidance on Qualification of Medical Device Development Tools

The U.S. Food and Drug Administration (FDA) has published its final Guidance on the...

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Tektronix Expands Catalog of High-Power Test and Measurement Devices

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