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The U.S. Food and Drug Administration (FDA) is once again seeking to ban the use of electrical stimulation devices in treating certain mental health issues.

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.

The FDA has published a draft guidance on assessing the thermal effects of medical devices that intentionally or unintentionally produce tissue temperature changes.

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.

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.

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

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

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

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