NEW YORK, NY--(Marketwire - Mar 6, 2012) - The Medical Equipment and Supplies Industry has performed well this year. The iShares Dow Jones U.S. Medical Devices Index Fund (IHI) -- which seeks to replicate a measurement of the performance of the medical equipment sector of the United States equity market, and includes medical equipment companies, such as manufacturers and distributors of medical devices, such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, x-ray machines, and other non-disposable medical devices -- is up in excess of 10 percent already in 2012. Five Star Equities examines the outlook for companies in the Medical Equipment & Supplies industry and provides equity research on Medtronic Inc. (NYSE: [ MDT ]) and Opko Health Inc. (NYSE Amex: [ OPK ]). Access to the full company reports can be found at:

[ www.fivestarequities.com/MDT ]

[ www.fivestarequities.com/OPK ]

After years of lax regulation, the FDA's top medical-device regulator said the agency needs more power to block unsafe products. According to Bloomberg, the debate centers on the agency's 510(k) program, which is used to clear 90 percent of medical products in the U.S. each year. The process can allow devices on the market without human testing if the FDA deems them "substantially equivalent" to previously approved versions, known as predicates. Changing the law "will bolster the strength of the 510(k) program, which repeatedly comes under criticism, and oftentimes, it's for just a handful of cases," Jeffry Shuren director of the FDA's Center for Devices and Radiological Health says.

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In 2008, the U.S. Supreme Court gave manufacturers immunity from lawsuits for any medical device that received "pre-market approval" from the Food and Drug Administration (FDA). Now, Congress is considering restoring some legal rights. The House Energy and Commerce Health Subcommittee hearing met last month to discuss the Medical Device User Fee Act (MDUFA), which was sent to Congress in February. It represents an agreement reached by the FDA and the device industry and would more than double the current user fee level of $287 million. Under the MDUFA proposal, a device company would have to pay about $220,000 to have its high-risk device reviewed under the FDA's premarket review process.

Jeffery Shuren told congress that doubling of user fees collected from device makers will improve the efficiency of FDA approvals.

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