Report: FDA’s Gottlieb says pediatric device approvals are lagging

FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report.

The statement came at a two-day FDA workshop this week, according to the report.

Barriers including sample size issues, regulatory concerns and problems with research infrastructure are keeping such devices from hitting the market, according to an audience poll from the workshop.

While the number for adult devices approved by the FDA grew at a rate of 3.8 per year between 2008 and 2017, pediatric devices grew at a much smaller rate of approximately 1 per year, according to RAPS.

The same trend is reflected in other submissions, including de novo and humanitarian device exemptions for pediatric patients, according to the report.

The FDA has launched initiatives looking to support development in the pediatric space, including a new division on pediatric internal medicine for drugs, according to the report. The agency is also “looking for new ways to protect children who participate in clinical trials,” Gottlieb said, according to RAPS.

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