- Providing Information about Pediatric Uses
- March 11, 2013
- Law Firm: Alston Bird LLP - Atlanta Office
On February 19, 2013, FDA also issued a supplemental notice of proposed rulemaking, along with a Draft Guidance, “Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act,” requiring certain submissions for medical devices to include “readily available pediatric use information.” The proposed rule would require any request for a HDE, any PMA or supplement, or any PDP to include any publicly available information about any pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose or cure, and the number of pediatric patients affected by the disease or condition.
The rule defines pediatric patients as persons 21 years of age and younger at the time of their diagnosis or treatment and includes the following subpopulations: neonates (birth to 28 days), infants (29 days to 2 years), children (2-12 years) and adolescents (12-21 years). The pediatric use information requirement would be met by providing information available in the public domain (e.g., research published in peer-reviewed medical journals) on U.S. subjects. Data on non-U.S. subjects should only be used in the absence of readily available information on U.S. subjects. The pediatric use information submission should briefly describe in narrative form the natural history of the disease or condition and include a description of the proposed indications for the device, as well as an estimate of the number of affected pediatric patients in the United States that suffer from the disease or condition that the device is intended to treat, diagnose or cure. The Guidance provides a table for how this information should be presented (Draft Guidance at 7).
FDA stated in its Draft Guidance that it will use this information to comply with the statutory requirement to provide an annual report to Congress that includes the number of devices approved that year for these pediatric populations. This is another reason why FDA requests “publicly available information;” since this information will be presented to Congress, FDA explicitly instructs sponsors to exclude proprietary, trade secret and commercial confidential information. The Agency also indicated that it would like to use this information to determine unmet pediatric needs in medical device development so that the Agency can coordinate with industry, stakeholders and FDA staff to promote development and proper labeling of pediatric devices. Of course, providing this information will not be sufficient to establish the safety and effectiveness of a device for a new pediatric indication.
This supplemental notice of proposed rulemaking is FDA’s second attempt to issue pediatric submission requirements. On April 1, 2010, FDA first issued a proposed rule along with a direct final rule, but later withdrew the direct final rule after receiving “significant adverse comments.” FDA will be accepting electronic or written comments on the newest proposed rule by April 22, 2013.