Press Releases

Congresswoman Lizzie Fletcher and Congressman Gus Bilirakis Introduce Bipartisan Legislation To Improve and Develop Pediatric Medical Devices

Today, Congresswoman Lizzie Fletcher (TX-07) and Congressman Gus Bilirakis (FL-12) introduced bipartisan legislation to help further development of pediatric medical devices by reauthorizing the Pediatric Device Consortia (PDC) grant program and allowing profits for certain Humanitarian Device Exemption (HDE) devices. 

Medical devices for children often lag five to ten years behind that of adults because of the unique challenges that device manufacturers face in creating safe and effective medical devices for children, such as differences in size, weight, and metabolism rate.  The market for pediatric devices is also smaller than the market for adult devices, leaving little economic incentive for manufacturers to develop these devices.  

To encourage manufacturers to create devices for children, Congress lifted the profit restrictions placed on pediatric devices that goes through the HDE pathway.  The HDE pathway is for devices that treat or diagnose a rare disease or condition that affects fewer than 8,000 people in the United States.  The PDC program brings together individuals and institutions to support pediatric medical device development, and assists scientists and innovators with technical and financial resources to improve the number of medical devices available to children. 

“Our children deserve the same commitment to the development of lifesaving and life-changing devices that we make to adults,” said Congresswoman Lizzie Fletcher.  “I am glad to partner with Congressman Bilirakis in this bipartisan effort to bring beneficial treatments and technologies to children across our country.”

“Manufacturing devices specifically made for pediatric patients has presented unique challenges and innovation has not kept pace with those developed for adults, leaving many children with rare diseases without devices that appropriately meet their individual needs,” said Congressman Gus Bilirakis.  “Our bipartisan legislation will help address this shortage by continuing to incentivize the development of child-specific medical devices that account for variables like size and body chemistry. By reauthorizing these successful pediatric and humanitarian device programs, we are taking an important step forward in ensuring that our youngest Americans have access to high quality health care.”

The PDC program funds five consortia throughout the United States.  The Southwest National Pediatric Device Innovation Consortium (SWPDC) is anchored by Texas Children’s Hospital and Baylor College of Medicine in Houston.     

To view full text of the bill, click here.