U.S. Food and Drug Administration (FDA)

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...

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

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

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

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