[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 54058-54059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22619]


-----------------------------------------------------------------------

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Draft Guidance for Industry; Special Control Guidance for 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.

-----------------------------------------------------------------------

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availability of the draft guidance for industry entitled ``Special 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reclassified, this draft guidance document will serve as the special 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DATES: Submit written comments on the draft guidance by October 6, 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of the draft guidance entitled ``Special Control Guidance for Premarket 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concerning this draft guidance to the Dockets Management Branch (HFA-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to the draft guidance.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