FDA Pediatric Medical Device Meeting Set To Discuss Getting New Devices To Market
Federal health officials have called for a public meeting later this summer, inviting all stakeholders to discuss medical device innovation to serve the complex needs of children, stating the current technology is lagging behind that of adults.
The U.S. Food and Drug Administration (FDA) announced they will be hosting a Pediatric Medical Device Development meeting on August 13 and 14, 2018, to discuss how to better improve medical devices for children under 21 years of age which has lagged in innovation.
The purpose of the meeting is to review and plan how to improve strategies to enhance the medical device ecosystem toward development and innovation of devices that can serve a variety of complex needs and medical conditions for children.
The meeting will focus on how to improve research infrastructure and research networks to encourage and improve clinical trials for pediatric devices. It will also look at how to extrapolate findings under current laws and guidelines.
The meeting will also look at improving the proper use of post market registries and data to make pediatric medical device labeling more accurate; how to increase FDA assistance to medical device manufacturers in developing devices for pediatric populations, and identify and address current barriers to the development of new pediatric medical devices.
The FDA classifies age ranges into pediatric subpopulations that are categorized as follows: Neonates – from birth through the first 28 days of life, Infants – 29 days to less than 2 years, Children – 2 years to less than 12 years, Adolescents – aged 12 through 21.
A study published in the online journal Pediatrics & TherapeuticsRecent warns that pediatric medical device development is approximately 10 years behind adult device development. One of the primary reasons given for the lack in innovation is that device manufacturers lack motivation to invest in developing pediatric devices, because they tend to be a much smaller market, which is a hurdle that the FDA intends to overcome in discussion.
The meeting will be held at the FDA White Oak Campus in Silver Spring, Maryland and will be open to all stakeholders including representatives from the medical device industry, academia, recipients of funding under the Section 305 of the Pediatric Medical Device Safety and Improvement Act, medical provider organizations, and organizations and individuals representing important public health issues.