Task Force Collaborating With FDA Issues Pediatric Heart Valve Recommendations-thegraysheet: The paper is published in the October issue of the Journal of Thoracic and Cardiovascular Surgery, along with a commentary from CDRH staff involved in efforts to promote the development of pediatric devices. “The approach presented in the article is consistent with FDA’s regulatory practices for surgically implanted heart valves, is capable of providing a reasonable assurance of safety and effectiveness, promotes pediatric device development, and represents the least burdensome approach to the important unmet need of pediatric heart valves,” the FDA staffers conclude.
