FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation Information in Certain Medical Device Submissions


On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical device applications (Docket No. FDA–2009–N–0458).i The Food and Drug Administration Amendments Act of 2007 (FDAAA) added section 515A to the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360e-1), which requires certain medical device submissions to include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. To implement this provision, FDA initially published a proposed rule and a companion direct final rule in the Federal Register in April 1, 2010. However, FDA withdrew the direct final rule in light of significant adverse comments received in response to it.

FDA made changes since the April 1, 2010 proposed rule, and accordingly, issued the notice of proposed rulemaking to allow for public comment on the re-drafted proposed rule. The notice of proposed rulemaking indicates that the requirement to submit readily available information about pediatric subpopulations applies to the following submission types, when submitted on or after the effective date of the rule: (1) any request for a humanitarian device exemption (HDE) submitted under section 520(m) of the FDCA; (2) any premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FDCA; and (3) any product development protocol (PDP) submitted under section 515 of the FDCA.

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