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Standards and Compliance

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.

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.

NIST Extends Deadline for Comments on Strategy for Critical and Emerging Technology

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has extended...

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...
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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...

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The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

NIST Releases Cybersecurity Framework 2.0 Draft

The National Institute of Standards and Technology (NIST) has recently published for public comment...
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