[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21401-21402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-0788]


Neurological Devices; Reclassification of the Totally Implanted 
Spinal Cord Stimulator; Denial of Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 
that it has denied a petition submitted by Advanced Neuromodulation 
Systems, Inc. (ANS), to reclassify the totally implanted spinal cord 
stimulator (SCS) for treatment of chronic intractable pain of the trunk 
or limbs from class III into class II. FDA had previously made 
available for public comment the recommendation of the Neurological 
Devices Panel (the Panel) on the reclassification petition and FDA's 
tentative findings on the Panel's recommendation. After considering all 
the available information, including the public comments on the Panel's 
recommendation, FDA denied the reclassification petition by order in a 
letter to the petitioner.

ADDRESSES: A copy of the denial order is available at the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

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-
1184.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et. seq.), as amended by the Medical Device Amendments 
of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical 
Devices Act of 1990 (Public Law 101-629), and the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the act (21 U.S.C. 360c) 
established three categories (classes) of devices, depending on the 
regulatory controls needed to provide reasonable assurance of their 
safety and effectiveness. The three categories of devices are class I 
(general controls), class II (special controls), and class III 
(premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the 1976 amendments enactment date), 
generally referred to as preamendments devices, are classified after 
FDA has: (1) Received a recommendation from a device panel (an FDA 
advisory committee); (2) published the panel's recommendation for 
comment, along with a proposed regulation classifying the device; and 
(3) published a final regulation classifying the device. FDA has 
classified most preamendments devices under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. A postamendment device remains in 
class III and requires premarket approval, unless and until the device 
is reclassified into class I or II or FDA issues an order finding the 
device substantially equivalent, under section 513(i) of the act, to a 
predicate device that does not require premarket approval. The agency 
determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the regulations.
    Reclassification of classified postamendments devices is governed 
by section 513(f)(3) of the act. This section allows FDA to initiate 
reclassification of a postamendments class III device under section 
513(f)(1) of the act, or a manufacturer or importer of a device may 
petition the Secretary of Health and Human Services (the Secretary) for 
the issuance of an order reclassifying the device in class I or class 
II.
    FDA's regulations in 21 CFR 860.134 set forth the procedures for 
the filing and review of a petition for reclassification of such 
postamendment class III devices. To change the classification of the 
device, it is necessary that the proposed new class have sufficient 
regulatory controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may, for 
good cause shown, refer a reclassification petition to a device panel 
for a recommendation on the subject device's classification. The panel 
shall make a recommendation to the Secretary respecting approval or 
denial of the petition. Any such recommendation shall contain: (1) A 
summary of the reasons for the recommendation, (2) a summary of the 
data upon which the recommendation is based, and (3) an identification 
of the risks to health (if any) presented by the device with respect to 
which the petition was filed.

II. Regulatory History of the Device

    The totally implanted SCS intended for treatment of chronic 
intractable pain of the trunk or limbs is a postamendments device 
classified into class III under section 513(f)(2) of the act. 
Therefore, the device cannot be placed in commercial distribution for 
treatment of chronic intractable pain of the trunk or limbs unless it 
is reclassified under section 513(f)(2) of the act, or subject to an 
approved PMA under section 515 of the act.
    On June 16, 1999, ANS submitted a petition to FDA that requested 
reclassification of the totally implanted SCS intended for treatment of 
chronic intractable pain of the trunk or limbs from class III into 
class II. Consistent with the act and the regulation, FDA referred the 
petition to the Panel for its recommendation on the requested 
reclassification.

III. Device Description

    The following device description is based on the Panel's 
recommendations and the agency's review: The totally implanted spinal 
control stimulator consists of an implanted pulse generator (IPG), 
leads, and electrodes. The IPG contains the internal power source that 
is implanted in the patient. The electrodes are placed on the patient's 
spinal cord and the leads from the electrodes are connected 
subcutaneously to the IPG.

[[Page 21402]]

IV. Recommendation of the Panel

    At a public meeting held on September 16 and 17, 1999, the Panel 
recommended that the totally implanted SCS intended for aid in the 
treatment of chronic intractable pain of the trunk or limbs be 
reclassified from class III into class II. In the Federal Register 
of September 6, 2000 (65 FR 54053), FDA published for public 
comment a notice of the Panel's recommendation and FDA's tentative 
findings on the Panel recommendation. FDA invited interested persons to 
comment by October 6, 2000. In response to a request, FDA later 
extended the comment period to November 4, 2000.

V. FDA's Decision

    FDA received 22 comments in response to the September 6, 2000, 
notice of panel recommendation. The comments are discussed in detail in 
the order denying the reclassification petition and in an attachment to 
that order. Although FDA's earlier tentative findings supported 
reclassification, the agency has now concluded that class II controls 
are not adequate to address the risks associated with the device. The 
most serious risk to health presented by the device is the risk of 
device failure. Device failure is frequently the result of improper 
device design. Device failure always requires reoperation with all of 
the attendant risks of secondary surgery. Many of the comments 
suggested that general controls and special controls could not 
adequately control the risk of device failure.
    After carefully reviewing the information in the petition, the 
information presented at the Panel meeting, the Panel's deliberations, 
the published literature, the Medical Device Reports, and the comments 
on the notice of panel recommendation, FDA has completed its evaluation 
of the risks to health associated with the use of the totally implanted 
SCS intended for treatment of chronic intractable pain of the trunk or 
limbs.
    FDA determined that the petitioner had not demonstrated that 
special controls would provide reasonable assurance of the safety and 
effectiveness of the device. Specifically, FDA determined that special 
controls, such as bench and animal testing, cannot substitute for 
actual clinical trials designed to demonstrate the safety and 
effectiveness of these devices. FDA also determined that the risks to 
health associated with the manufacturing process could only be 
addressed through the degree of regulatory oversight applied to class 
III devices. Therefore, on February 23, 2001, FDA issued an order to 
the petitioner denying the petition for reclassification.
    FDA has placed a copy of the order denying the petition on display 
at the Dockets Management Branch (address above) in the above 
referenced docket. A copy of the order may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 18, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-10619 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S