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Published on 4 August 2010

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FDA tightens medical device safety

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Under new US Food and Drug Administration regulations, medical device manufacturers will be forced to submit more detailed review rules and safety information, including the required information on the kind of operations that the device can and cannot perform.

The FDA’s chief aim is to facilitate the examination of devices, in case any device reported any kind of risk or malfunction.

The specific devices that will undergo scrutiny will include heart pacemakers, X-ray machines, and drug pumps.

According to the FDA, the current system is faster and less effective and does not give much space for the FDA officials to go through the devices before introducing them to the market.

According to the statistics, only 50 out of 4,000 devices are thoroughly tested before being granted approvals. The FDA also added that more regulations would be added to the new system, but these changes would need the Congress to pass new legislations.

FDA



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