FDA first premarket approvals for medtech products granted 2005-2018

This statistic displays the number of first premarket approvals (PMA/HDE) by the FDA for medtech products from 2005 to 2018. In 2008 there were 30 first new PMA/HDE. A PMA 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. The applicant is often the individual who owns the rights or has authorized access to the information required for submission.

Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2018

Number of PMA/HDE/PDP
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Sources

Release date

February 2019

Region

Worldwide

Survey time period

2005 to 2018

Supplementary notes

This statistic was assembled from several editions of the same publication.
PMA: pre-market approval.
HDE: humanitarian device exemption.

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