This week, Congresswoman Lizzie Fletcher’s (TX-07) and Congressman Gus Bilirakis’ (FL-12) bipartisan legislation to further the development of pediatric medical devices, H.R. 7679, passed the House.  The bill reauthorizes the Pediatric Device Consortia (PDC) grant program and allows profits for certain Humanitarian Device Exemption (HDE) devices.  It was included in a broader piece of legislation, the Food and Drug Amendments Act of 2022, H.R. 7667, which, among other things, reauthorizes the Food and Drug Administration’s (FDA) user fee programs and improves the FDA’s review of drugs, biologics, and medical devices.  The bill passed the House on a bipartisan basis, by a vote of 392-28.

“Houston is home to leading medical and research institutions, providing breakthrough technologies and treatments to patients across our country,” said Congresswoman Lizzie Fletcher.  “I am glad my legislation to provide lifesaving and life-changing medical devices for children passed the House, which will benefit patients and the medical community in Houston and across the country.  I am glad to partner with Congressman Bilirakis and thank our colleagues in the House for joining us in making smart investments to improve our country’s health system.”

In May, Congresswoman Fletcher and Congressman Bilirakis introduced H.R. 7679, the legislation to improve and develop pediatric medical devices.  The bill then passed the Energy and Commerce Committee when it was included in H.R. 7667.

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 the full text of the bill, click here.