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Count of first-time medtech approvals granted by FDA 2006-2017

This statistic displays the number of medtech first-time approvals (including PMAs/HDEs/PDPs - PMA: pre-market approval; HDE: humanitarian device excemption; PDP: product development protocol) granted by the FDA (Food and Drug Administration) per year from 2006 to 2017. In 2008 there were 30 first new PMAs/HDEs/PDPs. A PMA is a process undertaken by the FDA in the United States, to review and evaluate the safety and effectiveness of Class III medical devices. A traditional PMA application requires large volumes of information to be submitted such as device description and intended use, clinical studies, and labeling.

Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017*

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Sources

Release date

September 2018

Region

Worldwide

Survey time period

2006 to 2017

Supplementary notes

* PMA: pre-market approval; HDE: humanitarian device excemption; PDP: product development protocol.
** Added from previous editions of this report.

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