FDAnews Device Daily Bulletin

FDA Lays Down Roadmap for Extrapolating Adult Clinical Data for Pediatric Use

June 28, 2016

FDA is clarifying how and when existing adult clinical data may be extrapolated to support marketing approval and labeling of medical devices for use in pediatric patients.

Sponsors are encouraged to engage FDA early on when considering whether existing clinical data might support pediatric claims.

The agency notes in final guidance released June 21 that there is a dearth of scientific evidence to substantiate submissions for devices that diagnose or treat pediatric patients.

The guidance provides sponsors a roadmap on:

  • How to leverage relevant existing clinical data to increase availability of safe and effective pediatric devices;
  • When it may be appropriate to leverage this data to support pediatric device indications and labeling;
  • How to determine whether extrapolation is appropriate, and to what extent the data can be leveraged; and
  • How to describe statistical methodology that can be used to leverage data for pediatric indications.

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