Authored bipartisan legislation to incentivize, hasten development of devices specifically for children

Washington (May 9, 2014) – Senator Edward J. Markey (D-Mass.), co-author of the Pediatric Medical Device Safety and Improvement Reauthorization Act (PMDSIA), today sent a letter to the Food and Drug Administration (FDA) querying the agency about progress implementing the law and availability of reliable pediatric devices. The lack of readily available and safe medical devices intended for the pediatric population spurred Senator Markey to introduce PMDSIA. Medical therapeutic devices for children must be appropriately-sized, fit unique physiology and accommodate the rapid growth that accompanies the pediatric years. Since enactment of the law, the FDA has awarded seven pediatric device consortia grants across the country. 

“Our investment and focus on safe pediatric-specific medical therapies must grow as quickly as the children they will help heal,” said Senator Markey. “My law helps bring together federal government, scientists and innovators to focus their skills on developing pediatric devices that are tailored and respond uniquely to the needs of children. I look forward to hearing from the FDA on progress implementing this important law and getting these devices to the patients who need them.”

“Children are not just small adults; they need safe medical devices that are specifically designed for them,” said AAP President James M. Perrin, MD, FAAP. “The American Academy of Pediatrics supports the Pediatric Medical Device Safety and Improvement Act and commends its author, Senator Markey, for ensuring that as this law continues to be implemented, children’s needs are prioritized.”

A copy of the letter to the FDA can be found HERE. 

The Pediatric Medical Device Safety and Improvement Reauthorization Act, which passed in 2012 as a part of the reauthorization of the FDA Safety and Innovation Act, supports the continued development of medical devices intended specifically for children. The bipartisan legislation reauthorizes the original 2007 law co-authored by Senator Markey and Rep. Mike Rogers (R-Mich.) and includes a grant program to bring scientists and innovators together to hasten the development of pediatric devices. The bill also incentivizes the development of devices that serve children with rare conditions.