On July 9, 2012, the president signed into law a reauthorization of the Pediatric Medical Device Safety and Improvement Act of 2007, which as a result of the strong advocacy of AAP and other partner organizations, was included as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). The law's provisions are outlined below in detail.
Reauthorizes and preserves pediatric profit incentive
Devices for small populations (less than 4,000 patients) can be approved by the FDA under the humanitarian device exemption (HDE), which is not subject to the same requirements as large-market devices. Prior to 2007, HDE-approved devices were not allowed to make profit. Manufactures could only recoup their research and development costs. The AAP-championed 2007 law lifted the profit restriction for pediatric devices.
As a result, three pediatric devices have been approved since 2007 under this program and many more are expected in the coming years. Since passage, five times as many pediatric devices have received eligibility for the program. The bill also expands the program to adults while preserving the strength of the pediatric incentive
Reauthorizes the Pediatric Device Consortia
The AAP also successfully advocated for the reauthorization of the valuable Pediatric Device Consortia (PDC) program for five years at $5.25 million per year. The PDC, originally established in the the 2007 law, is a successful grant program to establish non-profit consortia to facilitate the development, production, approval, and distribution of pediatric devices. To date, the consortia have consulted on well over 130 device projects, several of which are now on the market.
Requires final rule on pediatric device tracking
The AAP also advocated that FDASIA require the FDA to finally implement a provision requiring medical and surgical device companies to submit available pediatric information in their device applications. FDASIA requires that the FDA publish a proposed rule by December 31, 2012 and a final rule by December 31, 2013.
2012 Device Law Reauthorization Resources