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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

Final
Docket Number:
FDA-2015-D-1376
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-1376.

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