The United States remains the leader for medical devices, accounting for about two-fifths of the worldwide market. An impending overhaul of the U.S. Food and Drug Administration’s 510(k) device approval protocols will help dictate the direction of the U.S. market share in the years to come. FDA unveiled a plan consisting of 25 actions the regulatory agency plans to implement in 2011 to improve the most common path to market for medical devices.
The emerging economies of Brazil, Russia, India, and China (BRIC) have transformed into profitable, high-growth medical device markets. These emerging economies are on the rise because of increasing use of medical devices due to growth in health awareness as well as for their offshore business operations and production.
This special report about medical device approvals includes the following information:
– A recap and analysis of the promising and anticipated medical devices approved by the U.S. Food and Drug Administration via the Premarket Approval (PMA) process during 2010 and early 2011.
– A complete listing of the medical devices cleared for marketing by FDA via the 510(k) Premarket Notification process in 2010, including the following details for each entry:
• Product code
• Product description
• Registration number
• Decision date