GUIDANCE DOCUMENT
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Guidance for Industry and Food and Drug Administration Staff June 2016
- Docket Number:
- FDA-2015-D-1376
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
The objectives of this guidance are: (1) to increase the availability of safe and effective pediatric devices by providing a roadmap for leveraging relevant existing clinical data for use in demonstrating a reasonable assurance of safety and effectiveness in pre-market approval applications (PMAs) and de novo requests, as well as for use in supporting approvals of humanitarian device exemptions (HDEs)3; (2) to explain the circumstances in which it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling; (3) to outline the approach FDA uses to determine whether extrapolation is appropriate, and, to what extent the data can be leveraged; and (4) to describe statistical methodology that can be used to leverage the data in a way that increases precision for pediatric inferences.
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2015-D-1376.