fda

The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on...

The U.S. Food and Drug Administration (FDA) has selected nine companies to participate in...

As part of its effort to streamline the approval process for high-risk medical devices,...

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

The U.S. Food and Drug Administration (FDA) has published an updated list of consensus...

The U.S. Food and Drug Administration (FDA) has announced its intention to revisit its...

The U.S. Food and Drug Administration (FDA) has extended the deadline for certain low-risk...

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...