Medical Device makers can find themselves required to address potential pediatric uses of their devices in two situations – where the device is intended for those under 21 and where the device is intended for adults but might be used for minors as well. Now there’s FDA guidance for pediatric uses of medical devices. Titled “Providing Information about Pediatric Uses of Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” it specifically addresses the information you need to submit with your device application to the FDA.
First the guidance document covers the situations where pediatric information needs to be included with a submission. This will help you understand exactly what information is required for compliance with Section 515A of the Federal Food, Drug, and Cosmetic Act. And acceptable sources for this specific information are also included.
Then pediatric patient populations and subpopulations are defined. This is useful for determining if you need to include older adolescents as a pediatric use group in your submittal, for example.
The next sections of the guidance document cover administrative issues. They include where to include the pediatric information, how to include it and how the FDA will use this information. The document wraps up with a discussion of what happens when the FDA finds your information to be insufficient to establish a new pediatric “indication.”
The FDA Guidance documents remain a useful tool in understanding the FDA regulatory process and requirements. They compliment the use of standards and other technical information so important during the submittal and premarket phase of the development of a medical device. You can get all this type of information from Document Center. We support the Medical Device community with a range of products and services to assure your compliance information collection is complete and correct.
Purchase the information you need at our webstore, www.document-center.com. Or contact the Document Center staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). If you need additional monitoring services, documentation audits, standing order service, or a regular reporting system, we’ve got those available for you. We even provide a current awareness service to inform you of new releases in the topic areas you need to keep on top of!
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