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; Direct Final Rule
fda-device · Food and Drug Administration · Rule · Published 2010-04-01 · Effective 2010-08-16 · 75 FR 16347
Document
Document number
2010-7193
Federal Register citation
75 FR 16347
CFR reference
21 CFR 814
Type
Rule
Action
Direct final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2010-04-01
Effective date
2010-08-16
HHS docket
Docket No. FDA-2009-N-0458
Abstract
The Food and Drug Administration (FDA) is 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. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.