Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e-1). Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions (HDEs), and product development protocols (PDPs) for new devices to include readily available information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure.
This guidance document describes how to compile and submit the readily available pediatric use information required under Section 515A of the FD&C Act. Topics covered include:
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the types of premarket submissions that must include the pediatric device use information;
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a description of the specific pediatric device use information required to comply with Section 515A of the FD&C Act;
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what is meant by “readily available information”;
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definitions of the pediatric patient population and of pediatric subpopulations;
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some acceptable sources that could address the 515A pediatric use information requirement;
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where to include the pediatric device use information within a submission;
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how to provide the pediatric device use information within the submission;
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what FDA will do with the submitted pediatric device use information; and
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why FDA does not consider the submitted pediatric device use information to be sufficient to establish a new pediatric indication.