Medical Devices; Humanitarian Use of Devices

[Federal Register Volume 63, Number 147 (Friday, July 31, 1998)]
[Rules and Regulations]
[Page 40825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20594]


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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is withdrawn effective July 31, 1998.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withdrawn.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