[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Rules and Regulations]
[Pages 44489-44491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2011-N-0466]


Medical Devices; Neurological Devices; Classification of 
Repetitive Transcranial Magnetic Stimulation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: 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.

DATES: This final rule is effective August 25, 2011.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C 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&C 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&C 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[reg] 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[reg] 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;
     Seizure;
     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
     Hearing loss.
    FDA believes that the class II special controls guidance document 
will aid in

[[Page 44490]]

mitigating the potential risks to health as described in table 1 of 
this document.

                                Table 1--Risks to Health and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
             Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Failure to identify correct patient        Clinical testing.
 population.
                                           Labeling.
Ineffective treatment....................  Nonclinical analysis and testing.
                                           Software life cycle and risk management.
                                           Clinical testing.
                                           Labeling.
Seizure..................................  Nonclinical analysis and testing.
                                           Clinical testing.
                                           Labeling.
Scalp discomfort, scalp burn, or other     Nonclinical analysis and testing.
 adverse effects.
                                           Software life cycle and risk management.
                                           Clinical testing.
                                           Labeling.
Magnetic field effects on functioning of   Non-clinical analysis and testing.
 other medical devices.
                                           Labeling.
Adverse tissue reaction..................  Biocompatibility.
Hazards associated with electrical         Electrical equipment safety.
 equipment.
                                           Labeling.
Hazards caused by electromagnetic          Electromagnetic compatibility.
 interference and electrostatic discharge
 hazards.
                                           Labeling.
Hearing loss.............................  Labeling.
----------------------------------------------------------------------------------------------------------------

    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 Sec.  882.5805.
    Following the effective date of the final classification rule, 
manufacturers will need to address the issues covered in the special 
controls guidance. However, the manufacturer need only show that its 
device meets the recommendations of the guidance or in some other way 
provides equivalent assurance of safety and effectiveness.
    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?

    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. Thus, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the economic impact of this rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 not a significant 
regulatory action under Executive Order 12866.
    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&C 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.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and Tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Does this final rule have federalism implications?

    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

[[Page 44491]]

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?

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520) is not required.

VI. What references are on display?

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Petition from Neuronetics, Inc., May 23, 2007.

List of Subjects in 21 CFR Part 882

    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 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

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



0
2. Section 882.5805 is added to subpart F to read as follows:


Sec.  882.5805   Repetitive transcranial magnetic stimulation system.

    (a) Identification. 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.
    (b) Classification. Class II (special controls). The special 
control is FDA's ``Class II Special Controls Guidance Document: 
Repetitive Transcranial Magnetic Stimulation System.'' See Sec.  
882.1(e) for the availability of this guidance document.

    Dated: July 20, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18806 Filed 7-25-11; 8:45 am]
BILLING CODE 4160-01-P