The FDA defines pediatric medical devices as those that “treat or diagnose diseases and conditions from birth through age 21”. As many are aware, the medical device industry has a continuing lack of approved devices for pediatric use. This is due to a variety of barriers, as noted in this 2004 Report to Congress, such as the small market for these devices, difficulty in obtaining clinical data for FDA approval, and increased liability for working such this vulnerable population. The FDA has formed a Pediatric Device Consortia (PDC) Grant Program specifically to support the development of pediatric device innovation. IMARC recently published a blog on this topic, discussing how the PDC FDA group has provided funding to several chosen non-profit organizations and research consortia in an attempt to jumpstart the advancement of new pediatric devices.
In fact, good news may be on the horizon! In this recent article published in The Gray Sheet, the FDA has assisted a task force with the development of a white paper intended to help manufacturers earn pre-market approvals (PMAs) for pediatric heart valve replacements. The FDA’s recommendation is that heart valve manufacturers should focus on earning approval for pediatric valves that have already been approved for use in adults. By going the route of earning a PMA, sponsors can likely manufacture many more devices than if these were only used in Humanitarian Device Exemption (HDE) scenarios, which is the other option. The most important difference with a PMA is that many more pediatric patients have the potential to be treated, rather than the <4,000 individuals per year required for an HDE.
However, there are still many factors to consider regarding pediatric devices; as discussed here, “pediatric values are not just shrunken adult valves”. The article goes on to specifically note that although congenital heart valve disease is one of the most common abnormalities in children, we do not yet have many solutions available for treating this population. Hopefully, the recommendations of the task force and FDA will help spur the innovation for this, and other, pediatric devices.
There is still a long way to go in regards to pediatric devices approvals. Please share your thoughts or recommendations on this issue!
Photo Credit: Rachel Allyson