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
fda-device · Food and Drug Administration · Rule · Published 2014-01-10 · Effective 2014-04-10 · 79 FR 1735
Document
Document number
2014-00267
Federal Register citation
79 FR 1735
CFR reference
21 CFR 814
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-01-10
Effective date
2014-04-10
HHS docket
Docket No. FDA-2009-N-0458
Abstract
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.