Change Ethical Issues for Kids’ Products: AdvaMed

AdvaMed is proposing a change to an FDA draft guidance on ethical considerations for clinical investigations of medical products involving children. The association says that to promote the development of pediatric medical devices, the guidance should include relevant information on when adult data can be extrapolated for pediatric use from another guidance referenced in this draft.

“To de-risk pediatric medical device development,” AdvaMed says, “additional guidance and information from FDA on when children are required for a study to generate evidence of the prospect of clinical benefit versus when extrapolation is appropriate would be valuable. This could be done via examples of both where extrapolation is acceptable and where it may not be. These examples should also include examples of when anatomic or physiological correlations between adults and children may allow for extrapolation or not.”