[Federal Register: September 6, 2000 (Volume 65, Number 173)]
[Notices]
[Page 54058-54059]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se00-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1455]
Draft Guidance for Industry; Special Control Guidance for
Premarket Notifications for Totally Implanted Spinal Cord Stimulators
for Pain Relief; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance for industry entitled ``Special
Control Guidance for Premarket Notifications for Totally Implanted
Spinal Cord Stimulators for Pain Relief.'' Elsewhere in this issue of
the Federal Register, FDA is issuing a notice of a panel recommendation
to reclassify totally implanted spinal cord stimulators from class III
(premarket approval) to class II (special controls). If this device is
reclassified, this draft guidance document will serve as the special
control for the reclassified device. This guidance is neither final nor
in effect at this time.
DATES: Submit written comments on the draft guidance by October 6,
2000.
ADDRESSES: Submit written requests for single copies on a 3.5" diskette
of the draft guidance entitled ``Special Control Guidance for Premarket
Notifications for Totally Implanted Spinal Cord Stimulators for Pain
Relief'' to the Division of Small Manufacturers Assistance (DSMA) (HFZ-
220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
request, or fax your request to 301-443-8818. Submit written comments
concerning this draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the docket
number found in brackets in the heading of this document. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Russell P. Pagano, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1296.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Special Control Guidance for Premarket Notifications for Totally
Implanted Spinal Cord Stimulators for Pain Relief.'' Elsewhere in this
issue of the Federal Register, FDA is issuing a notice of a panel
recommendation to reclassify totally implanted spinal cord stimulators
from class III (premarket approval) to class II (special controls). If
this device is reclassified, this draft guidance document will serve as
the special control for the reclassified device.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on special controls for totally implanted spinal cord
stimulators for pain relief. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
applicable statute, regulations, or both.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is
[[Page 54059]]
issued as a Level 1 guidance consistent with GGP's.
III. Electronic Access
In order to receive the draft guidance entitled ``Special Control
Guidance for Premarket Notifications for Totally Implanted Spinal Cord
Stimulators for Pain Relief'' via your fax machine, call the CDRH
Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a
touch-tone telephone. At the first voice prompt press 1 to access DSMA
Facts, at second voice prompt press 2, and then enter the document
number 1179 followed by the pound sign (#). Then follow the remaining
voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the Internet. The Center for Devices and Radiological
Health (CDRH) maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with access to the Internet. Updated on a
regular basis, the CDRH home page includes ``Special Control Guidance
for Premarket Notifications for Totally Implanted Spinal Cord
Stimulators for Pain Relief,'' device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh.
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft guidance by October 6,
2000. 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. The
draft guidance and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: August 21, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-22619 Filed 9-5-00; 8:45 am]
BILLING CODE 4160-01-F