[Federal Register: July 31, 1998 (Volume 63, Number 147)]
[Rules and Regulations]
[Page 40825]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy98-14]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N-0171]


Medical Devices; Humanitarian Use of Devices

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 17, 1998 (63 FR 19185), a direct final rule
to implement the amendments to the humanitarian use devices provision
of the Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Food and Drug Administration Modernization Act of 1997 (FDAMA). The
comment period closed July 1, 1998. FDA is withdrawing the direct final
rule because the agency received significant adverse comment.

DATES: The direct final rule published at 63 FR 19185, April 17, 1998,
is withdrawn effective July 31, 1998.

FOR FURTHER INFORMATION CONTACT: Joanne R. Less, Center for Devices and
Radiological Health (HFZ-403), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20857, 301-594-1190.

    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 17, 1998, at 63 FR 19185 is
withdrawn.

    Dated: July 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20594 Filed 7-30-98; 8:45 am]
BILLING CODE 4160-01-F