[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
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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.
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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