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Regulatory Focus™ > News Articles > 8 > Gottlieb: FDA Approvals for Pediatric Devices Continue to Lag

Gottlieb: FDA Approvals for Pediatric Devices Continue to Lag

Posted 13 August 2018 | By Ana Mulero 

Gottlieb: FDA Approvals for Pediatric Devices Continue to Lag

The past decade has seen “far too few devices” on the US market designed specifically for diagnosing and treating pediatric populations despite recent legislative actions, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said during a public workshop Monday.
The pediatric device sector is fraught with challenges, noted participants at the first day of the two-day workshop, which forms part of a renewed push for pediatric medical device development.
The issue of small sample sizes top the list of participants’ biggest barriers to generating evidence in support of a pediatric device indication, followed by regulatory considerations and research infrastructure, an audience poll showed.
These barriers have contributed to the current lack of devices with pediatric indications approved via the premarket approval pathway, participants argued.
The number of devices approved for adult use grew at a faster pace from 2008 to 2017, with a rate of four (3.8) per year vs. just one (0.96) for pediatrics. This lag is illustrated in the graphic below from Mary Clare McCorry, a scholar at FDA’s Center for Devices and Radiological Health (CDRH).
The trend is reflected in other types of device submissions to CDRH, including de novo designation requests as well as humanitarian use devices and humanitarian device exemptions.

With an aging population in the US, the impact these challenges can have on the pediatric device sector is expected to be even greater.
“Improvise is not a word parents want to hear from their kid’s doctor,” said Kurt Newman, president and CEO at Children's National Health System. “Yet pediatric specialists have to jury rig care because many of the medical devices needed to treat sick children are built for adults.”
FDA, however, has launched several initiatives aimed at encouraging further development in the space and increasing the number of pediatric devices. These include the addition of a new division on pediatric internal medicine for drugs, Gottlieb noted. The agency is also “looking for new ways to protect children who participate in clinical trials,” he added.
Other potential solutions endorsed by participants include creating new incentives for companies to innovate in the sector and tackling issues related to Institutional Review Boards.


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