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Pediatric Medical Device Development –FDA Public Meeting 8/13/18

Medical device development for children lagged behind that for adults. FDA workshoop held to identify strategies that enhance the medical device ecosystem toward development and innovation of devices that serve the complex needs of children, and thereby accelerate medical device innovation for all Americans.

Highlights:

  • Need to improve research infrastructure and research networks to the conduct of clinical studies of pediatric devices, appropriately use extrapolation under section 515A(b), enhance the appropriate use of post-market registries and data to increase pediatric medical device labeling,  increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and finally identify current barriers to pediatric device development and incentives to address such barriers. (identify current barriers and incentives)
  • FDA plan to dedicate in promoting timely access to safe and effective medical devices for all patients, and recognizes the unique needs of pediatric patients, despite a recognized need, relatively few medical devices have pediatric-specific indications and labeling
  • Increase availability of safe and effective pediatric devices by providing a roadmap for leveraging relevant existing clinical data for use in premarket approval applications (PMAs), humanitarian device exemptions (HDEs), and de novo request
  • Explain circumstances in which the FDA believes it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling
  • Outline the approach FDA uses to determine whether extrapolation is appropriate, and if so, to what extent the data can be leveraged
  • Describe suggested statistical methodology that may be used to leverage the data in a way that increases precision for pediatric inferences
  • Incentives to increase investor interest and reimbursement success

Appropriateness of data extrapolation can be considered separately for effectiveness and safety 

  • Full extrapolation: existing clinical data may be used directly for prospective pediatric clinical data
  • Partial extrapolation: existing data are combined via a statistical model with pediatric data sources or prospective pediatric clinical data
  • Partial extrapolation permits utilization of existing clinical data to support demonstration of device safety or effectiveness for use in pediatric patients, with the expectation that some pediatric data are necessary
  • FDA comment about data extrapolation:  Extrapolated data may be used, not necessarily mean the data will support an approval decision

FDA Commissioner stated: we’re committed to supporting the development and availability of safe and effective pediatric medical devices, and to encourage device innovation for medical conditions that impact young populations.  Pediatric Device Consortia Grant Program and the Humanitarian Device Exemption pathway have helped foster the approval of a number of pediatric-specific medical devices and devices with a pediatric indication.

Workshop Information

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