[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Rules and Regulations]
[Pages 18236-18237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 00P-1120]


Medical Devices; Gastroenterology-Urology Devices; Nonimplanted, 
Peripheral Electrical Continence Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
nonimplanted, peripheral electrical continence device into class II 
(special controls). The special controls that will apply to this device 
are set forth below. The agency is taking this action in response to a 
petition submitted under the Federal Food, Drug, and Cosmetic Act (the 
act) as amended by the Medical Device Amendments of 1976, the Safe 
Medical Devices Act of 1990, and the Food and Drug Administration 
Modernization Act of 1997. The agency is classifying this device into 
class II (special controls) in order to provide a reasonable assurance 
of safety and effectiveness of the device.

DATES: This rule is effective May 8, 2000.

FOR FURTHER INFORMATION CONTACT: Laura J. Byrd, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the Medical Device Amendments of 
1976 (the amendments), generally referred to as postamendments devices, 
are classified automatically by statute into class III without any FDA 
rulemaking process. These devices remain in class III and require 
premarket approval, unless and until the device is classified or 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with 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 marketed 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 FDA regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1), request FDA to classify the device under the criteria set 
forth in section 513(a)(1). FDA shall, within 60 days of receiving such 
a request, classify the device by written order. This classification 
shall be the initial classification of the device. Within 30 days after 
the issuance of an order classifying the device, FDA must publish a 
notice in the Federal Register announcing such classification.
    On January 24, 2000, UroSurge, Inc., submitted a petition under 
section 513(f)(2) of the act requesting classification of its 
Percutaneous SANS Device intended for use in patients suffering from 
urinary urgency, frequency, or urge incontinence. After review of the 
information submitted in the petition and the premarket notification 
(K992069), FDA issued an order on February 9, 2000, classifying the 
UroSurge Percutaneous SANS (Stoller Afferent Nerve Stimulator) Device 
and substantially equivalent devices of this generic type into class II 
under the generic name, ``nonimplanted, peripheral nerve stimulator for 
pelvic floor dysfunction.'' FDA has determined that the nonimplanted, 
peripheral nerve stimulator for pelvic floor dysfunction can be 
classified in class II with the establishment of the following special 
controls:
    1. That sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec. 801.109 (21 CFR 801.109).
    2. That the labeling must bear all information required for the 
safe and effective use of the device as outlined in Sec. 801.109(c), 
including a detailed summary of the clinical information upon which the 
instructions are based.
    FDA believes that these class II special controls, in addition to 
the general controls, provide reasonable assurance of the safety and 
effectiveness of the device.

II. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so it is not subject to review under the Executive Order. The 
Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Classification of these devices into class II will relieve 
manufacturers of the device of the cost of complying

[[Page 18237]]

with the premarket approval requirements of section 515 of the act (21 
U.S.C. 360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs. FDA knows of only one manufacturer 
of this type of device. The agency therefore certifies that the final 
rule will not have a significant impact on a substantial number of 
small entities. In addition, this final rule will not impose costs of 
$100 million or more on either the private sector or State, local, and 
tribal governments in the aggregate, and, therefore, a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act is not required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    1. The authority citation for 21 CFR part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Section 876.5310 is added to subpart F to read as follows:


Sec. 876.5310  Nonimplanted, peripheral electrical continence device.

    (a) Identification. A nonimplanted, peripheral electrical 
continence device is a device that consists of an electrode that is 
connected by an electrical cable to a battery-powered pulse source. The 
electrode is placed onto or inserted into the body at a peripheral 
location and used to stimulate the nerves associated with pelvic floor 
function to maintain urinary continence. When necessary, the electrode 
may be removed by the user.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) That sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec. 801.109 of this chapter.
    (2) That the labeling must bear all information required for the 
safe and effective use of the device as outlined in Sec. 801.109(c) of 
this chapter, including a detailed summary of the clinical information 
upon which the instructions are based.

    Dated: March 29, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-8596 Filed 4-6-00; 8:45 am]
BILLING CODE 4160-01-F