There’s a new FDA Draft Guidance document available, “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.” This new draft guidance will help medical device developers and manufacturers understand the FDA’s take on the extrapolation of clinical data. And since it’s a draft document, there’s time to review and comment in order to influence how the FDA will allow for the use of existing data for the expansion of the approved patient population for your device.
Why is this draft guidance being released? The FDA hopes to increase the availability of safe and effective pediatric devices. It feels that companies can leverage existing data that has been generated for the PMA (pre-market approval application) process by the use of extrapolation. Further, additional relevant information is available from humanitarian device exemptions.
How would this extrapolated information be used? The FDA suggests a methodology for using this data to support pediatric device indications and labeling. This will provide the FDA with the rationale for the approval of expanded use.
What will you learn in this draft document? The FDA is releasing this guide to help you understand the approach they will be using to judge if extrapolation is appropriate. You’ll also learn their take on the extent to which data can be leveraged in this way. And you’ll be presented with a statistical methodology that the FDA believes increases the precision for pediatric inferences.
Additionally there are two Appendices in this guidance document. The first gives you an example of the decision process for extrapolation. The second covers various details on the statistical modeling processes you’ll be using.
Using medical devices developed for adults to assist younger patients is a worthy goal but certainly there are issues that cannot be ignored. Pediatric patients are still growing, have a different and developing body mass, and present device developers with a different range of issues than adults do. However, it is clear that there are many times when these devices may be of real value to pediatric patients. This draft guidance is a big step towards providing device manufacturers with a clear path to an approval process for such use by leveraging information they’re already collected.
You’ll need to get a copy of this publication now in order to meet the 90 day submission deadline for any comments you may have. Why don’t you consider purchasing it from Document Center Inc.? You’ll be able to get the draft guidance in either paper or pdf format and if and when it is adopted by the FDA, we’ll notify you via an email alert. Just head to our webstore at www.document-center.com. Or click on this link to go to the order page for “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.” If you have questions, you’re welcome to get in touch with our staff directly by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Remember, we’re your Standards Experts!