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Compliance In Focus
Posted by John Lehmann on Tue, Oct 22, 2013

FDA Addresses Shortage of Child-Friendly Devices

The FDA is taking steps to jumpstart the development of medical devices for children throughFDA Addresses Shortage of Child Friendly Devices grants to non-profit organizations and research consortia.   The grants which total $18 million were announced by the agency on September 25th. 

Recipients of the grants include:

The goal is not the development of specific devices, but to spur development and act as advisors to innovators that they feel offer promise.  They hope to bring more devices to serve the needs of the pediatric market.  According to HHS, the applicants were selected based on their business, financial, regulatory, scientific/engineering, clinical and intellectual property expertise.

The market for pediatric devices is limited due to the smaller pool of children in need of medical compared to the population of elderly and middle-aged parents.   From a sponsor’s standpoint, the investment in these devices can be difficult when compared to adult devices which offer greater patient applicability.

The funding for the pediatric device consortia was initially authorized  by the FDA Amendments Act of 2007. The funding was reauthorized last year in the FDA Safety and Innovation Act.

The grants are administered by FDA’s Office of Orphan Product Development.  The consortia will also coordinate with the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.

What are your thoughts on this FDA initiative?  Will it help jumpstart medical device develop for this underserved market?  Share your thoughts below.

Photo Credit: Paige Filloon

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Topics: Medical Devices, Child-Friendly Devices, Pediatric Market, FDA

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