Most of the 66 medical devices that the FDA approved for pediatric patients in the 2017 fiscal year were initially intended and approved for adults, the agency said in a new annual report to Congress.
Of the total, 16 were premarket approvals (PMAs) and two were humanitarian device exemptions (HDEs) specifically designed for children. The remaining 47 PMAs and one HDE were indicated for use in adults.
Former FDA head Scott Gottlieb said in 2018 that over the previous 10 years there had been “far too few” devices hitting the U.S. market designed specifically for a pediatric population. Efforts continue among pediatric healthcare providers to increase the number of devices approved for pediatric use. Some medical device companies don’t invest as much into researching and developing pediatric devices because the market is small.
The FDA said it has approved a total of 447 PMAs and HDEs for pediatric patients, for an average of about 45 device approvals per year, since its first report to Congress for FY 2008. The highest number was in FY 2016 (71) and the lowest was 20, in FY 2010.
The FDA Reauthorization Act of 2017 added a section to require more information regarding the number of devices approved by the agency’s secretary after s/he determines that approving pediatric labeling on devices approved for adults could benefit pediatric patients.
The FY 2017 report covers the period from October 1, 2016, through September 30, 2017. It does not include the reporting data required under the new section because the agency was not capturing data for the secretary to determine whether such off-label devices could benefit pediatric patients if labeled for their use.
The FDA said it intends to include this data starting with the FY 2018 report. Previous pediatric annual reports to Congress can be found here.
