Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N-0168]

Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review

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 27, 1998 (63 FR 20530), a direct final rule

to implement the amendments to the premarket approval provisions of the

Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug

Administration Modernization Act of 1997 (FDAMA). The comment period

closed on July 13, 1998. FDA is withdrawing the direct final rule

because the agency received significant adverse comment.

DATES: The direct final rule published at 63 FR 20530, April 27, 1998,

is withdrawn on August 11, 1998.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ-402), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2186.

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 27, 1998, at 63 FR 20530 is

withdrawn.

Dated: August 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-21470 Filed 8-10-98; 8:45 am]

BILLING CODE 4160-01-F