fda

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.

Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices...

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

The U.S. Food and Drug Administration (FDA) has issued a Final Rule that establishes...

The U.S. Food and Drug Administration (FDA) is reporting the voluntary recall of certain...

The U.S. Food and Drug Administration (FDA) has announced plans to improve consumer access...

In an effort to make information on the use of certain higher-risk home-use medical...

HeartWare is recalling its Ventricular Assist Device (HVAD) with serial numbers lower than HW25838. A design problem...