Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal
fda-device · Food and Drug Administration · Rule · Published 2010-07-20 · 75 FR 41986
Document
Document number
2010-17617
Federal Register citation
75 FR 41986
CFR reference
21 CFR 814
Type
Rule
Action
Direct final rule; withdrawal.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2010-07-20
HHS docket
Docket No. FDA-2009-N-0458
Abstract
The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, a direct final rule that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment.