Pediatric Expertise Guidance Differentiates Among Four Populations Under 21
This article was originally published in The Gray Sheet
Executive Summary
Requirements of the Medical Device User Fee & Modernization Act (Sec. 210) related to premarket panel consultations are expanded upon in a 1pediatric expertise guidance released May 30
You may also be interested in...
Pediatric Device Reforms Presented To Policymakers By Advocacy Groups
Firms modifying devices for pediatric patients should receive fast-tracked product review, according to a proposal generated by two children's organizations and other stakeholders
Pediatric Device Reforms Presented To Policymakers By Advocacy Groups
Firms modifying devices for pediatric patients should receive fast-tracked product review, according to a proposal generated by two children's organizations and other stakeholders
CDRH Prepares Pediatric Device, Study Criteria; Focus Is On Age Stratification
FDA is stressing the need to account for characteristics of particular age ranges when designing and testing devices and in vitro diagnostics for pediatric patients