Source: https://www.federalregister.gov/documents/2000/04/07/00-8596/medical-devices-gastroenterology-urology-devices-nonimplanted-peripheral-electrical-continence
Timestamp: 2018-07-21 06:37:23
Document Index: 682714711

Matched Legal Cases: ['art 807', '§\u2009801', '§\u2009801', '§\u2009876', '§\u2009801', '§\u2009801']

Federal Register :: Medical Devices; Gastroenterology-Urology Devices; Nonimplanted, Peripheral Electrical Continence Device
Docket No. 00P-1120
https://www.federalregister.gov/d/00-8596 https://www.federalregister.gov/d/00-8596
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.
Laura J. Byrd, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194.
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.
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 § 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 § 801.109(c), including a detailed summary of the clinical information upon which the instructions are based.
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 Start Printed Page 18237with 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.
2. Section 876.5310 is added to subpart F to read as follows:
§ 876.5310
Nonimplanted, peripheral electrical continence device.
(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 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 § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.
[FR Doc. 00-8596 Filed 4-6-00; 8:45 am]