FDA first premarket approvals for medtech products granted 2005-2022

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.