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FDA Publishes White Paper on AI and Medical Products

Recognizing the growing deployment and use of AI-enabled technologies, the U.S. Food and Drug Administration has published a white paper on the use of AI in medical products and devices.

FDA Updates Thermal Effects Guidance for Medical Devices

The FDA has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.

FDA Updates Its Recognized Standards List

The FDA has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

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.

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.
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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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