[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Rules and Regulations]
[Pages 45716-45717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N-0170]


Medical Device Reporting: Manufacturer Reporting, Importer 
Reporting, User Facility Reporting, Distributor Reporting

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 May 12, 1998, a proposed rule (63 FR 26129) and a 
direct final rule (63 FR 26069) to implement amendments to the medical 
device reporting provisions of the Federal Food, Drug, and Cosmetic 
Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The 
comment period closed July 27, 1998. FDA is withdrawing the direct 
final rule because the agency received significant adverse comment.

EFFECTIVE DATE: The direct final rule published at 63 FR 26069, May 12, 
1998, is withdrawn on August 27, 1998.

[[Page 45717]]

FOR FURTHER INFORMATION CONTACT: Patricia A. Spitzig, Center for 
Devices and Radiological Health (HFZ-500), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2812.

    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 May 12, 1998, at 63 FR 26069 is 
withdrawn.

    Dated: August 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-22926 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F