FDA Awards Seven Grants to Stimulate Pediatric Medical Device Innovation
- By BSTQ Staff
In September 2013, the U.S. Food and Drug Administration (FDA) awarded $3.5 million in grants to enhance the availability and development of medical devices for children. FDA’s Office of Orphan Products Development presented the grants to seven pediatric device organizations, each with a team of specialists with expertise in delivering regulatory, business, scientific, engineering, legal and clinical services for children.
Children present a unique challenge to the medical device developer community because their body chemistry, stature and growth rate differ from child to child. Medical device legislation was passed by Congress in 2007 to help establish a continuous flow of funding for nonprofit institutions to help stimulate projects to promote the advancement of pediatric devices. This legislation was re-approved as part of the FDA Safety and Innovation Act of 2012.
Grant recipients intend to accomplish four goals: inspire creation and unite skilled individuals with innovative pediatric device ideas to prospective manufacturers; guide pediatric device projects through their development, including prototype design and marketing; join innovators and healthcare professionals with available federal and non-federal resources; and evaluate the scientific and medical merit of suggested pediatric projects and offer support and advice on industry growth, training, prototype development and post-marketing requirements.
This is the third time since 2009 that FDA has presented grants to pediatric medical device organizations. Each of the seven grant recipients will coordinate with FDA, device companies and the Eunice Kennedy Shriver National Institute of Child Health and Human Development to promote research and the advancement of any necessary applications for device clearance and approval. In addition, they will work with FDA to guide innovators through current laws and regulations to create safe and effective medical devices for children of all ages.
