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*
Profit from the additional features of your individual account
Currently, you are using a shared account. To use individual functions (e.g., mark statistics as favourites, set
statistic alerts) please log in with your personal account.
If you are an admin, please authenticate by logging in again.
Learn more about how Statista can support your business.
Evaluate. (September 28, 2018). Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017* [Graph]. In Statista. Retrieved September 20, 2024, from https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/
Evaluate. "Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017*." Chart. September 28, 2018. Statista. Accessed September 20, 2024. https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/
Evaluate. (2018). Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017*. Statista. Statista Inc.. Accessed: September 20, 2024. https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/
Evaluate. "Number of Medtech First-time Approvals (Pma/Hde/Pdp) Granted by The Fda per Year from 2006 to 2017*." Statista, Statista Inc., 28 Sep 2018, https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/
Evaluate, Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017* Statista, https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/ (last visited September 20, 2024)
Number of medtech first-time approvals (PMA/HDE/PDP) granted by the FDA per year from 2006 to 2017* [Graph], Evaluate, September 28, 2018. [Online]. Available: https://www-statista-com.ezproxy.canberra.edu.au/statistics/331716/fda-first-premarket-approvals-in-us-per-year/