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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.

FDA Withdraws from Global Harmonization Working Party

Citing increasingly divergent harmonization efforts for medical devices, the U.S. Food and Drug Administration...

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...

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...

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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The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...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 Issues Warning About Ultraviolet Wands

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers about...

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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Military and Aerospace EMC: Bandwidths Used in Measurements

FDA Annual Medical Device Regulations Conference Set

Manuel Sierra Castañer Awarded Distinguished AMTA Honor

AMTA Awards Life Membership Award to Peter Collins

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