FDA first premarket approvals for medtech products granted 2005-2018

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

by Matej Mikulic, last edited Mar 26, 2019
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.
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Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2018

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Number of PMA/HDE/PDP
201935
201750
201640
201551
201433
201323
201241
201143
201022
200918
200830
200732
200644
200534
Number of PMA/HDE/PDP
201935
201750
201640
201551
201433
201323
201241
201143
201022
200918
200830
200732
200644
200534
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by Matej Mikulic, last edited Mar 26, 2019
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.
Show more
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