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  • 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.

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Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.