Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
Information
Type
Rule
Regulated products
Medical Devices
Published
January 10, 2014
Last updated
January 10, 2014
Description
Document number 2014-00267. The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)