This statistic displays the number of first premarket approvals (PMA/HDE) by the FDA for medtech products from 2005 to 2022. In 2022, there were 23 first new PMA/HDEs. 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. The applicant often 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 2022
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Evaluate Vantage. (February 9, 2023). Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022 [Graph]. In Statista. Retrieved September 01, 2024, from https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/
Evaluate Vantage. "Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022." Chart. February 9, 2023. Statista. Accessed September 01, 2024. https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/
Evaluate Vantage. (2023). Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022. Statista. Statista Inc.. Accessed: September 01, 2024. https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/
Evaluate Vantage. "Number of First Premarket Approvals (Pma/Hde) Granted by The Fda for Medtech Products from 2005 to 2022." Statista, Statista Inc., 9 Feb 2023, https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/
Evaluate Vantage, Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022 Statista, https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/ (last visited September 01, 2024)
Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022 [Graph], Evaluate Vantage, February 9, 2023. [Online]. Available: https://www.statista.com/statistics/331683/first-premarket-approvals-medtech-products-fda/