Document ID: FDA-2009-N-0458-0010
Agency: fda
Document Type: Rule
Title: Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information, etc.: Withdrawal
Posted Date: 2010-07-20T04:00Z

[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Rules and Regulations]               
[Page 41986]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy10-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2009-N-0458]
RIN 0910-AG29

 
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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

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SUMMARY: 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.

DATES: The direct final rule published at 75 FR 16347, April 1, 2010, 
is withdrawn on July 19, 2010.

FOR FURTHER INFORMATION CONTACT: Robert Gatling, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796-6560.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, the 
direct final rule published on April 1, 2010, at 75 FR 16347 is 
withdrawn.

    Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17617 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S