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

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1998, is withdrawn on August 27, 1998.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withdrawn.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