[Federal Register Volume 59, Number 144 (Thursday, July 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18444]


[Federal Register: July 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0118]


Preamendments Class III Devices; Strategy Document; Availability; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
September 6, 1994, the comment period for a notice that announced the 
availability of the document entitled ``Preamendments Class III 
Devices; Strategy Document; Availability'' that appeared in the Federal 
Register of May 6, 1994. The document sets forth the agency's strategy 
for implementing the provisions of the Safe Medical Devices Act of 1990 
(the SMDA) which require FDA to review the classification of certain 
class III (premarket approval) devices, and either reclassify the 
devices into class I (general controls) or class II (special controls) 
or retain them in class III. The statute also requires FDA to establish 
a schedule for requiring the submission of premarket approval 
applications (PMA's) for those devices retained in class III.

DATES: Written comments by September 6, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-4765, ext 157.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 6, 1994 (59 
FR 23731), FDA announced the availability of a document that sets forth 
the agency's strategy for implementing the provisions of the SMDA which 
require FDA to review the classification of certain class III 
(premarket approval) devices, and either reclassify the devices into 
class I (general controls) or class II (special controls) or retain 
them in class III. The statute also requires FDA to establish a 
schedule for requiring the submission of PMA's for those devices 
retained in class III. Interested persons were invited to comment by 
August 4, 1994. FDA received one request for an extension of the 
comment period for 30 days. The request stated that extension was 
necessary to provide interested persons sufficient time to review all 
of the devices listed in the document.
    FDA finds under section 520(d) (21 U.S.C. 360j(d)) that there is 
good cause for granting a 30-day extension to provide sufficient time 
for review and comments. Accordingly, the comment period is extended to 
September 6, 1994.
    Interested persons may, on or before September 6, 1994, submit to 
the Dockets Management Branch (address above), written comments 
regarding this notice. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 25, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-18444 Filed 7-27-94; 8:45 am]
BILLING CODE 4160-01-F