GUIDANCE REGARDING PEDIATRIC DEVICES.

SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES. Not later than 270 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance on the following: 116 STAT. 1615 (1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations. (2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices.