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
Proposed Rule
Regulated products
Medical Devices
Published
April 1, 2010
Last updated
April 1, 2010
Description
Document number 2010-7192. The Food and Drug Administration (FDA) is proposing to amend 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. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)