Could you give me any documents about approval process for medical devices in US?

Any data on the length of time, increase or decrease over the years, etc, concerning the approval process for medical devices before they can be approved, manufactured and sold in the US by the FDA, Federal Drug Administration.

The Medical Device Amendments were signed into law on May 28, 1976. At this time, medical devices were classified into three classes, and Class III devices (those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury) became subject to premarketing approval (PMA) by the FDA (the Food and Drug Administration).

FDA regulations require that the FDA review the PMA and make a determination within 90 days of receiving the PMA. However, it can take many years to generate the data necessary to file a PMA.

The length of time to generate the data for a PMA is different for each device.

More information is available at the FDA's "Device Advice" website.

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