[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Page 67345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 95N-0176]
Orthopedic Devices: Classification, Reclassification, and
Codification of Pedicle Screw Spinal Systems; Extension of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to March
4, 1996, the comment period for the proposed rule that published in the
Federal Register of October 4, 1995 (60 FR 51946). The document
proposed to classify certain unclassified preamendments pedicle screw
spinal systems into class II (special controls), and to reclassify
certain postamendments pedicle screw spinal systems from class III
(premarket approval) to class II. FDA is taking this action in response
to several requests for an extension to assure adequate time for
preparation of comments.
DATES: Written comments by March 4, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mark N. Melkerson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 4, 1995
(60 FR 51946), FDA published a proposed rule to classify certain
unclassified preamendments pedicle screw spinal systems into class II
(special controls), and to reclassify certain postamendments pedicle
screw spinal systems from class III (premarket approval) to class II.
FDA is proposing to place certain pedicle screw spinal systems in class
II because the agency believes that sufficient information exists to
establish special controls to provide reasonable assurance of its
safety and effectiveness.
Interested persons were invited to comment by January 2, 1996. FDA
received several requests to extend the comment period, including a
request from a United States District Court Judge presiding over
product liability actions concerning orthopedic bone screw products.
The court requested that FDA allow a 60-day extension because court
orders relating to the disclosure of certain information about pedicle
screws may make it difficult for parties involved in the litigation to
submit relevant information to FDA by January 2, 1996.
Because FDA wants to provide adequate time for the submission of
all relevant information related to these important public health
issues, FDA is extending the comment period for 60 days. Accordingly,
FDA finds under section 520(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(d)) that there is good cause for such an extension.
Interested persons may, on or before March 4, 1996, submit to
Dockets Management Branch (address above) written comments regarding
this proposal. 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: December 21, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-31460 Filed 12-28-95; 8:45 am]
BILLING CODE 4160-01-F
