(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.
The guide also features:
• A comprehensive overview of the FDA’s regulatory framework for medical devices, from requirements to registering as a device maker to postmarket obligations
• A summary for each of the 65 device-related guidance documents included in the guide
• A rundown on the Center for Devices and Radiological Health’s future plans for its medical-device regulation system
Already the Center for Devices and Radiological Health has revealed plans to strengthen premarket review, enhance data collection, improve tracking of devices and adverse events, harmonize standards with other nations, and share inspections data with foreign regulators.
Failure to heed FDA regulations is a sure path to refusals, 483s, and warning letters, not to mention liability lawsuits that could bankrupt a company.
The 2011 Guide to Medical Device Regulations is available in print or PDF formats for $397. Please mention priority code 11N17 when ordering. Order online, or by calling toll-free (888) 838–5578 (in the United States) or 1 (703) 538–7600 (outside of the United States).