Source: https://www.federalregister.gov/articles/2011/07/26/2011-18806/medical-devices-neurological-devices-classification-of-repetitive-transcranial-magnetic-stimulation
Timestamp: 2015-08-30 09:56:57
Document Index: 300863412

Matched Legal Cases: ['art 807', 'art 807', '§ 882', 'art 882', '§ 882', '§ 882']

Federal Register | Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System
Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System
Dates: This final rule is effective August 25, 2011.
-44491 (3 pages)
Docket No. FDA-2011-N-0466
Document Number: 2011-18806
Shorter URL: https://federalregister.gov/a/2011-18806 Related Topics
The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
This final rule is effective August 25, 2011.
Ann H. Costello, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2460, Silver Spring, MD 20993-0002, 301-796-6493.
I. What is the background of this rulemaking? Back to Top
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD 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, 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 the device is classified or reclassified into class I or class II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD Act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD Act (21 U.S.C. 360(k)) and part 807 of FDA's regulations (21 CFR part 807).
Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C 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 must, within 60 days of receiving such a request, classify the device by written order. This classification will be the initial classification of the device type. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing this classification (section 513(f)(2) of the FD&C Act).
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on April 27, 2007, classifying the NeuroStar® TMS System for the treatment of major depressive disorder in patients who have failed to receive benefit from one antidepressant trial into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device that was subsequently reclassified into class I or class II. On May 23, 2007, Neuronetics, Inc., submitted a petition requesting classification, under section 513(f)(2) of the FD&C Act, of the NeuroStar® TMS System for the treatment of major depressive disorder in patients who have failed to receive benefit from one antidepressant trial. The manufacturer recommended that the device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the rTMS system can be classified into class II with the establishment of special controls. FDA believes that these special controls, in addition to general controls, are adequate to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System,” which will serve as the special control for rTMS systems.
The device is assigned the generic name “Repetitive Transcranial Magnetic Stimulation System.” A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
FDA has identified the risks to health associated with this type of device as follows:
Failure to identify correct patient population;
Ineffective treatment;
Scalp discomfort, scalp burn, or other adverse effects;
Magnetic field effects on functioning of other medical devices;
Adverse tissue reaction;
Hazards associated with electrical equipment;
Hazards caused by electromagnetic interference and electrostatic discharge hazards; and
Failure to identify correct patient population
Nonclinical analysis and testing.
Software life cycle and risk management.
Scalp discomfort, scalp burn, or other adverse effects
Magnetic field effects on functioning of other medical devices
Non-clinical analysis and testing.
Electrical equipment safety.
Hazards caused by electromagnetic interference and electrostatic discharge hazards
FDA believes that the special controls, in addition to general controls, address the risks to health identified previously in this document and provide reasonable assurances of the safety and effectiveness of the device type. Thus, on October 7, 2008, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification by adding § 882.5805.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirement under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, the type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the rTMS system they intend to market.
II. What is the environmental impact of this rule? Back to Top
III. What is the economic impact of this rule? Back to Top
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device into class II will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the FD Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
IV. Does this final rule have federalism implications? Back to Top
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. 21 U.S.C. 360k. See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls established by this final rule create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).
V. How does this rule comply with the paperwork reduction Act of 1995? Back to Top
VI. What references are on display? Back to Top
1. Petition from Neuronetics, Inc., May 23, 2007.
1.The authority citation for 21 CFR part 882 continues to read as follows: Authority:
2.Section 882.5805 is added to subpart F to read as follows: § 882.5805 Repetitive transcranial magnetic stimulation system.
(b) Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
[FR Doc. 2011-18806 Filed 7-25-11; 8:45 am]