(FDAnews: Falls Church, VA) -- It’s your job to know the FDA’s medical device regulations inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights.

In its first revision in three years, the 2011 Guide to Medical Device Regulations is the most comprehensive, authoritative, up-to-the-minute guide to device regulations available anywhere. It includes full texts of every device-related regulation currently in force, plus executive summaries and analyses outlining their impact on companies like yours.

You’ll discover back-to-basics explanations of premarket submissions; user fees and how they work; guidance on inspection procedures and practices; reporting and tracking requirements; guidance on labeling; and FDA priorities for future regulatory initiatives.

 …