Earlier this year, we wrote a blog on the shortage of pediatric devices. To address this issue the FDA is ramping up efforts to promote the development of pediatric devices in 2014. On June 9th the agency issued a final ruling that requires firms to include readily available information about the pediatric subpopulations that could benefit from a medical device under submission. The FDA is also in the final stages of issuing a draft guidance on the extrapolation of adult data for pediatric uses of devices.
The goal of the guidance is to help both industry and the FDA establish consistency in their approaches to determine whether it is appropriate to pull adult data to pediatric indications. We wrote a blog on how the pediatric market is underserved and how the FDA partnered with the Pediatric Consortia Funds to help overcome the shortage.
Pediatric devices often are designated as humanitarian use devices (HUD) because the disease/condition they are intended to treat affects fewer than 4,000 Americans per year. A HUD can only be used in a particular facility after an institutional review board (IRB) has approved their use. Many feel this mandate impedes the development of pediatric devices and would like the statute to be reconsidered.
The Safe Medical Device Act created in 1990 was created to make sure companies did not use this to get around the PMA. Diane Dorman, Vice President at the National Organization for Rare Disorders (NORD) indicated that only Congress can undo the IRB approval requirements for HUDs. Obviously this can be an emotional issue for parents whose children have life-threatening conditions. The associate director for science at the Center for Devices and Radiological Health, Michelle McMurry-Heath, provides reassurance to those parents by indicating that an initiative maybe underway to take into account the individual patient and their risk tolerances during the decision-making process for approval.
On April 10th, the final rule will go into effect for the “Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure.” This final ruling will include that submissions must provide “a description of any pediatric subpopulations that suffer from the disease or condition that device is intended to treat, diagnose, or cure, and the number of affected pediatric patients,” if the information is readily available. Also, the FDA is working on finalizing the draft guidance before this final rule goes into affect on April 10th. The goal of the final rule and draft guidance is assist Sponsors in reporting this important information to the FDA, which will aide the growth devices being approved for pediatric indications.
Please share your thoughts on this FDA initiative below.
Photo Credit: anantal