Devices considered substantially equivalent to products in these 26 categories continue to be cleared for the market through the 510(k) process.

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In many cases all the manufacturer has to do is show that a device is reasonably safe and "substantially equivalent" to other legally marketed devices.

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But the new law included a loophole called 510(k) that remains today: A device can be approved with few or no clinical trials if it is deemed "substantially equivalent" to a gadget that existed before 1976.

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Where processes required by the Manual, such as a requirement of approval by specified Department of Defense officials, are inapposite to a department or an agency other than the Department of Defense, such a department or agency shall use processes that are substantially equivalent to the processes the Manual prescribes for the Department of Defense.

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Abdul cites the example of a cardiovascular drug that was launched at a price substantially cheaper than the imported equivalent available in the market.

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