US Medical Device Recalls Market Analysis by GBI Research Now Available at MarketPublishers.com14 May 2012 • by Natalie Aster
LONDON – Large and rapidly growing, the medical devices industry is often complicated by legal technicalities. Hence, it is important to maintain regulatory surveillance on medical devices to protect public health by assessing the safety and effectiveness of medical devices.
According to the US Food and Drug Administration (FDA), the number of medical device recalls per year increased from 578 in 2005 to 928 in 2010. All in all, there were 4,343 medical device recalls during the same period. The main reasons behind these recalls were problems with device design and process control; the incorrect labeling of medical devices and the mistaken use of materials and components; as well as medical devices that pose a risk to patient health, devices that violate law, products with sterility failure and maintenance problems, and product repairs and contamination.
New market report “Regulatory Intelligence on Medical Device Recalls - Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall” drawn up by GBI Research provides true insights into the US medical device recalls market.
- basic concepts of medical device recalls – device classification and the device recall process by the FDA;
- medical device recalls in the US by year, recall class, number of recalls in different therapeutic areas and root cause;
- in-depth analysis of the top 10 recall firms in the US from 2005 to 2010, by year and by recall class;
- regulatory framework for medical devices in the following countries – the US, the UK, Germany, France, Spain, Italy and Japan.
Title: Regulatory Intelligence on Medical Device Recalls - Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall
Published: April, 2012
Price: US$ 3,500
More new market reports by the publisher can be found at GBI Research page.
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