Date of this Version
- The Pediatric Medical Device Safety and Improvement Act (PMDSIA) was passed in 2007 to increase the number of pediatric devices approved by the Food and Drug Administration (FDA).
- PMDSIA also led to the introduction of the Pediatric Device Consortia grant program, which promotes institutions to pass new pediatric devices.
- In the past, people relied on nontraditional methods of gaining capital for medical device development.
- Since the act, pediatric devices have still lagged behind FDA-approved adult medical devices due to various clinical hurdles, including the small market size, which can result in a limited return on investment (ROI), a challenge for private investors.
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Phoumyvong, Claire and Maltese, Matthew
"Pediatric Medical Device Development Pathways,"
Academic Entrepreneurship for Medical and Health Scientists: Vol. 1
, Article 8.
Available at: https://repository.upenn.edu/ace/vol1/iss3/8