[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Proposed Rules]
[Pages 17093-17099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7637]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 890
[Docket No. FDA-2009-N-0493]
RIN 0910-ZA37
Neurological and Physical Medicine Devices; Designation of
Special Controls for Certain Class II Devices and Exemption From
Premarket Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
certain neurological device and physical medicine device regulations to
establish special controls for these class II devices and to exempt
some of these devices from the premarket notification requirements of
the Federal Food, Drug, and Cosmetic Act. Elsewhere in this issue of
the Federal Register, FDA is publishing a notice of availability of
draft guidance documents that would serve as special controls for each
of these devices if the rule is finalized.
DATES: Submit written or electronic comments by July 6, 2010. See
section III of this document for the proposed effective date of a final
rule based on this proposed rule.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0493 and/or RIN number 0910-ZA37, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [for paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions must include the agency name and
docket number and Regulatory Information Number (RIN) (if a RIN number
has been assigned) for this rulemaking. All comments will be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002, e-
mail: [email protected], 301-796-6630.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authority
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Device Amendments
(SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act (FDAMA) (Public Law 105-115) established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on or
after May 28, 1976 (generally referred to as postamendments devices)
are classified automatically by statute (section 513(f) of the act)
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless FDA initiates the
following procedures: (1) FDA reclassifies the device into class I or
II; (2) FDA issues an order classifying the device into class I or II
in accordance with section 513(f)(2) of the
[[Page 17094]]
act; or (3) FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the act, to a predicate device that
is already legally marketed. The agency determines whether new devices
are substantially equivalent to predicate devices through review of
premarket notifications under section 510(k) of the act (21 U.S.C.
360(k)). Section 510(k) of the act and the implementing regulations,
part 807 (21 CFR part 807), require persons who intend to market a new
device to submit a premarket notification report (510(k)) containing
information that allows FDA to determine whether the new device is
``substantially equivalent'' within the meaning of section 513(i) of
the act to a legally marketed device that does not require premarket
approval.
Section 510(m)(2) of the act provides that FDA may exempt a device
from the premarket notification requirement on its own initiative or
upon petition of an interested person, if FDA determines that a 510(k)
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. This section requires FDA to publish in
the Federal Register a notice of intent to exempt a device, or of the
petition, and to provide a 30-day comment period. Within 120 days of
publication of this document, FDA must publish in the Federal Register
its final determination regarding the exemption of the device that was
the subject of the notice.
II. The Proposed Rule
A. Establishment of Special Controls
Under section 513(a)(1)(B) of the act, as amended by SMDA, class II
devices are defined as devices for which general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance. Special controls
may include the promulgation of performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and other appropriate actions the agency
deems necessary to provide such assurance (21 CFR 860.3(c)(2)).
Consistent with this authority, FDA is proposing to amend the
neurological devices regulations to establish special controls for
electroconductive media (Sec. 882.1275 (21 CFR 882.1275)) and the
cutaneous electrode (Sec. 882.1320 (21 CFR 882.1320)). FDA is also
proposing to amend the neurological devices regulation at Sec.
882.5890 (21 CFR 882.5890) to add paragraphs for the transcutaneous
electrical nerve stimulator for pain relief (Sec. 882.5890(a)), the
transcutaneous electrical nerve stimulator for pain relief intended for
over the counter use (Sec. 882.5890(b)), the transcutaneous electrical
nerve stimulator with limited output for pain relief (Sec.
882.5890(c)), the percutaneous electrical nerve stimulator for pain
relief (Sec. 882.5890(d)), the transcutaneous electrical stimulator
for aesthetic purposes (Sec. 882.5890(e)), and the transcutaneous
electrical stimulator with limited output for aesthetic purposes (Sec.
882.5890(f)).
Similarly, FDA is proposing to amend the physical medicine devices
regulation at Sec. 890.5850 (21 CFR 890.5850) to add paragraphs for
the powered muscle stimulator for rehabilitation (Sec. 890.5850(a)),
the powered muscle stimulator with limited output for rehabilitation
(Sec. 890.5850(b)), the powered muscle stimulator for muscle
conditioning (Sec. 890.5850(c)), and the powered muscle stimulator
with limited output for muscle conditioning (Sec. 890.5850(d)). FDA
believes that subdividing the classification regulations for each of
these device types would provide clarity for persons referencing the
classification regulation.
FDA is also proposing to establish special controls for each of
these device types. Elsewhere in this issue of the Federal Register,
FDA is publishing a notice of availability of the following draft
guidance documents that would serve as special controls:
(1) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Electroconductive Media;
(2) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Cutaneous Electrode;
(3) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
for Pain Relief;
(4) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
for Pain Relief Intended for Over the Counter Use;
(5) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator
with Limited Output for Pain Relief;
(6) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Stimulator for
Aesthetic Purposes;
(7) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Transcutaneous Electrical Stimulator with
Limited Output for Aesthetic Purposes;
(8) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator for
Rehabilitation;
(9) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator with Limited
Output for Rehabilitation;
(10) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator for Muscle
Conditioning; and
(11) Draft Guidance for Industry and FDA Staff; Class II Special
Controls Guidance Document: Powered Muscle Stimulator with Limited
Output for Muscle Conditioning.
The agency believes that the applicable special controls and general
controls will provide reasonable assurance of the safety and
effectiveness for each of the foregoing device types.
B. Exemption From Premarket Notification Requirements
Together with the establishment of special controls, FDA, on its
own initiative, is also proposing to exempt some of these device types
from premarket notification, subject to limitations. FDA may consider a
number of factors in determining whether premarket notification is
necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff.'' The guidance can be obtained
electronically at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm.
FDA believes that the following class II devices are appropriate
for exemption from premarket notification, subject to the limitations
of exemptions identified in Sec. Sec. 882.9 and 890.9 (21 CFR 882.9
and 890.9), because the applicable special controls and general
controls provide reasonable assurance of safety and effectiveness if
device manufacturers follow the special controls guidances'
recommendations and, for the transcutaneous electrical nerve stimulator
with limited output for pain relief and the powered muscle stimulator
with limited output for rehabilitation, if the devices are also
restricted to sale, distribution, and use
[[Page 17095]]
in accordance with the prescription device requirements in Sec.
801.109 (21 CFR 801.109):
Electroconductive media (Sec. 882.1275);
Cutaneous electrode (Sec. 882.1320);
Transcutaneous electrical nerve stimulator with limited
output for pain relief (Sec. 882.5890(c));
Transcutaneous electrical stimulator with limited output
for aesthetic purposes (Sec. 882.5890(e));
Powered muscle stimulator with limited output for
rehabilitation (Sec. 890.5850(b)); and
Powered muscle stimulator with limited output for muscle
conditioning (Sec. 890.5850(d)).
FDA is inviting comment on these proposed exemptions.
FDA advises that exemption from the requirement of premarket
notification does not mean that these devices would be exempt from any
other statutory or regulatory requirements, unless such exemption is
explicitly provided by order or regulation. Indeed, FDA's proposal to
exempt these device types from the requirement of premarket
notification is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements (21 CFR part 820), provide.
III. Proposed Effective Date
FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register. If finalized, following the effective date of a final
rule, any firm intending to market the applicable device types will
need to address the issues covered in the respective special controls
guidances. Unless otherwise exempt, the firm must show in its 510(k)
that its device meets the requirements of Sec. 807.87 and complies
with the special controls.
As discussed previously in this document, if the rule is finalized,
for six of the device types, manufacturers who follow the specific
measures recommended to address the issues identified in the special
controls guidances would be able to market their devices without being
subject to the premarket notification requirements of section 510(k) of
the act, subject to the limitations of Sec. Sec. 882.9 and 890.9.
Manufacturers of two of these six device types, transcutaneous
electrical nerve stimulator with limited output for pain relief and
powered muscle stimulator with limited output for rehabilitation, would
also be restricted to sale, distribution, and use in accordance with
the prescription device requirements in Sec. 801.109 in order to be
able to market their devices without being subject to premarket
notification. Manufacturers who choose alternative means to address one
or more of the issues identified in the applicable special controls
guidance would remain subject to the premarket notification
requirements of section 510(k) and would need to obtain marketing
clearance for their device.
IV. 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.
V. Analysis of Impacts
FDA has examined the impacts of the proposed 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 proposed rule is not a significant regulatory action as defined by
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 the devices discussed in this
proposed rule into class II with special controls will simplify the
process of bringing these devices to market. In addition, exemption
from the premarket notification requirements for six of these devices
would reduce the costs associated with bringing the devices to market.
Thus, the agency proposes to certify 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 $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
The special controls required by this proposed rule for the 11
listed devices do not impose significant costs because they do not add
new regulatory requirements. Instead, the special controls clarify FDA
expectations and should shorten the time to market for some new or
modified devices. Manufacturers of devices exempt from the premarket
notification requirements would no longer have to wait until they
receive a substantial equivalence determination from FDA before
marketing the device. For manufacturers of devices that still require
premarket notification, the special controls clarify FDA's expectations
making compliance with the general and special controls more
straightforward and should shorten the time to prepare a submission and
for FDA review. Moreover, manufacturers of devices that become exempt
from the premarket notification requirement would also benefit from the
elimination of application preparation time and of paper, copying, and
mailing costs by not having to prepare and submit 510(k)s. These
application savings are negligible, however, relative to the total cost
of bringing a medical device to market.
The sector of the device industry covered by the proposed rule is
part of the Electromedical and Electrotherapeutic Apparatus
Manufacturing sector, NAICS code 334510. The Small Business
Administration classifies firms in this sector as small if they have
fewer than 500 employees. About 90 percent of firms in this sector are
small, employing about 25 percent of the sector's work force. Table 1
lists the number of manufacturers for the different types of devices,
an estimate of the number of 510(k)s submitted each year (based on
historical ranges), and our best estimate of the percentage of new
devices that would be exempt from the premarket notification
requirement for each type of device.
[[Page 17096]]
Table 1.--Number of Manufacturers and 510(k)s per Year
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No. of No. of 510(k)s per
Device Type Manufacturers\1\ Year\2\ Percentage Exempt
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Electroconductive media 21 0-5 >90%
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Cutaneous electrode 76 5-15 >90%
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Transcutaneous electrical nerve stimulator 110 15-25 60%
for pain relief
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Transcutaneous electrical stimulator for 4 0-5 60%
aesthetic purposes
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Powered muscle stimulator for 81 10-20 50%
rehabilitation
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Powered muscle stimulator for muscle 12 0-8 50%
conditioning
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\1\ Manufacturers make multiple device types.
\2\ Data from 2000-2009.
The potential impact on small firms would be to reduce the cost of
entry by shortening the time to market for those firms who plan to
market these devices. It will impose no additional regulatory burden on
small entities, and it may permit some small potential competitors to
enter the marketplace by lowering their costs. Therefore the agency
proposes to certify that the final rule will not have a significant
economic impact on a substantial number of small entities.
VI. Federalism
FDA has analyzed this proposed 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 law 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 v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, 128 S. Ct. 999 (2008)). If this proposed rule is made final,
the special controls established by the final rule would create
``requirements'' for specific medical devices under 21 U.S.C. 360k,
even though product sponsors have some flexibility in how they meet
those requirements (Papike v. Tambrands, Inc., 107 F.3d 737, 740-742
(9th Cir. 1997)).
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no new
collection of information; however, consistent with the regulatory
impact analysis in section V of this document, we anticipate that the
exemption of 6 devices types from the premarket notification
requirements of the act will result in a reduction in burden to
existing collections of information currently approved under OMB
control number 0910-0120.
Accordingly, with respect to the collection of information
discussed below, FDA invites comments on these topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
This proposed rule designates guidance documents and other special
controls for certain neurological and physical medicine devices and
exempts certain of these devices from premarket notification
requirements. FDA expects an overall reduction in burden hours for
manufacturers of the six device types that FDA is proposing to exempt
from the premarket notification reporting requirements. The current
burden associated with submitting a premarket notification submission
under part 807, subpart E is 79 hours per submission at a cost of $100
per hour resulting in a total cost of $7,900 per submission. As
identified elsewhere in this document, the six device types being
exempted from the premarket notification requirements of the act will
no longer be subject to this burden. Based on FDA's estimates of annual
premarket notifications submitted for the exempted device types (table
2 of this document), FDA estimates a total burden reduction of 34.25
annual premarket notification submissions (90% of 2.5)+(90% of 10)+(60%
of 20)+(60% of 2.5)+(50% of 15)+(50% of 4)), 2,706 hours (34.25
submissions x 79 hours), and $270,600 (2,706 hours x $100 hourly rate).
Table 2.--Average Number of Manufacturers and Premarket Notifications (510(k)s) per Year for Proposed Exempt
Device Types
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No. of No. of 510(k)s per
Device Type Manufacturers\1\ Year\2\ Percentage Exempt
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Electroconductive media 21 2.5 > 90%
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Cutaneous electrode 76 10 > 90%
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Transcutaneous electrical nerve stimulator 110 20 60%
for pain relief
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Transcutaneous electrical stimulator for 4 2.5 60%
aesthetic purposes
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[[Page 17097]]
Powered muscle stimulator for rehabilitation 81 15 50%
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Powered muscle stimulator for muscle 12 4 50%
conditioning
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\1\Manufacturers make multiple device types.
\2\Data averaged from 2000-2009.
The guidance documents designated as special controls for each of
these 11 device types do not impose significant costs because they do
not add new regulatory requirements. Instead, the special controls
clarify FDA expectations and should shorten the time to market for some
new or modified devices. For manufacturers of devices that still
require premarket notification, the special controls clarify FDA's
expectations making compliance with the general and special controls
more straightforward and should shorten the time to prepare a
submission and for FDA review. While this clarification in expectations
may reduce the actual burden associated with submitting a premarket
notification submission for these specific device types, this reduction
is negligible when accounting for the size of entire premarket
notification program. Accordingly, FDA will not be adjusting the per
submission burden estimate of 79 hours for premarket notification
submissions accounted for under OMB control number 0910-0120.
VIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday.
List of Subjects
21 CFR Part 882
Medical devices, Neurological devices.
21 CFR Part 890
Medical devices, Physical medicine devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 882 and 890 be amended as follows:
PART 882--NEUROLOGICAL DEVICES
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.
2. Section 882.1275 is amended by revising paragraph (b) to read as
follows:
Sec. 882.1275 Electroconductive media.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Electroconductive Media.'' See
Sec. 882.1(e) for the availability of this guidance document. The
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter, subject to the limitations in Sec.
882.9, when it follows the recommendations of the special controls
guidance.
3. Section 882.1320 is amended by revising paragraph (b) to read as
follows:
Sec. 882.1320 Cutaneous electrode.
* * * * *
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Cutaneous Electrode.'' See Sec.
882.1(e) for the availability of this guidance document. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec. 882.9, when it
follows the recommendations of the special controls guidance.
4. Section 882.5890 is revised to read as follows:
Sec. 882.5890 Transcutaneous electrical nerve stimulator for pain
relief.
(a) Transcutaneous electrical nerve stimulator for pain relief--(1)
Identification. A transcutaneous electrical nerve stimulator for pain
relief is an electrically powered device used to apply an electrical
current to electrodes on a patient's skin to relieve pain. This does
not include the device types classified in paragraphs (b) through (f)
of this section.
(2) Classification. Class II (special controls). The special
controls for this device are:
(i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain
Relief.'' See Sec. 882.1(e) for the availability of this guidance
document; and
(ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter.
(b) Transcutaneous electrical nerve stimulator for pain relief
intended for over-the-counter use--(1) Identification. A transcutaneous
electrical nerve stimulator for pain relief intended for over-the-
counter use is an electrically powered device intended for over-the-
counter use and used to apply an electrical current to electrodes on a
patient's skin to relieve pain. This does not include the device types
classified in paragraphs (a) and (c) through (f) of this section.
(2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical Nerve
Stimulator for Pain Relief Intended for Over the Counter Use.'' See
Sec. 882.1(e) for the availability of this guidance document.
(c) Transcutaneous electrical nerve stimulator with limited output
for pain relief--(1) Identification. A transcutaneous electrical nerve
stimulator with limited output for pain relief is an electrically
powered device that is used to apply an electrical current to
electrodes on a patient's skin to relieve pain. This does not include
the device types classified in paragraphs (a) through (b) and (d)
through (f) of this section. The device utilizes a stimulus generator
that delivers, into a resistive load, which represents the worse case
of either 500 ohms or the typical load expected during normal
conditions of use, the following:
(i) A maximum charge per phase that does not exceed Q, where Q = 20
+
[[Page 17098]]
(28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
(ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
(iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
(iv) An average direct current (dc) that does not exceed 100
microamperes when no pulses are being applied, or if the device fails;
(v) A maximum current density that does not exceed 2 milliamperes
root mean square (rms) per square centimeter of electrode conductive
surface area; and
(vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
(2) Classification. Class II (special controls). The special
controls for this device are:
(i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Transcutaneous Electrical Nerve Stimulator with
Limited Output for Pain Relief.'' See Sec. 882.1(e) for the
availability of this guidance document; and
(ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations of exemptions in Sec. 882.9, when it
follows the recommendations of the special controls guidance and its
sale, distribution, and use are restricted to prescription use in
accordance with the prescription device requirements in Sec. 801.109
of this chapter.
(d) Percutaneous electrical nerve stimulator for pain relief--(1)
Identification. A percutaneous electrical nerve stimulator for pain
relief is an electrically powered device used to apply an electrical
current to electrodes that pass through a patient's skin to relieve
pain. This does not include the device types classified in paragraphs
(a) through (c) and (e) through (f) of this section.
(2) Classification. Class II (special controls). The special
control for this device is restriction of sale, distribution, and use
to prescription use in accordance with the prescription device
requirements in Sec. 801.109 of this chapter.
(e) Transcutaneous electrical stimulator for aesthetic purposes--
(1) Identification. A transcutaneous electrical stimulator for
aesthetic purposes is an electrically powered device applied externally
to the body surface using cutaneous electrodes to deliver electrical
current into the body, and is intended to achieve aesthetic effects
through physical change to the structure of the body. This does not
include the device types classified in paragraphs (a) through (d) and
(f) of this section.
(2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator for Aesthetic Purposes.'' See Sec. 882.1(e) for the
availability of this guidance document.
(f) Transcutaneous electrical stimulator with limited output for
aesthetic purposes--(1) Identification. A transcutaneous electrical
stimulator with limited output for aesthetic purposes is an
electrically powered device that is applied externally to the body
surface using cutaneous electrodes to deliver electrical current into
the body, and is intended to achieve aesthetic effects through physical
change to the structure of the body. This does not include the device
types classified in paragraphs (a) through (e) of this section. The
device utilizes a stimulus generator that delivers, into a resistive
load, which represents the worse case of either 500 ohms or the typical
load expected during normal conditions of use, the following:
(i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
(ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
(iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
(iv) An average dc that does not exceed 100 microamperes when no
pulses are being applied, or if the device fails;
(v) A maximum current density that does not exceed 2 milliamperes
rms per square centimeter of electrode conductive surface area; and
(vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
(2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator with Limited Output for Aesthetic Purposes.'' See Sec.
882.1(e) for the availability of this guidance document. The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations of exemptions in Sec.
882.9, when it follows the recommendations of the special controls
guidance.
PART 890--PHYSICAL MEDICINE DEVICES
5. The authority citation for 21 CFR part 890 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
6. Section 890.5850 is revised to read as follows:
Sec. 890.5850 Powered muscle stimulator.
(a) Powered muscle stimulator for rehabilitation--(1)
Identification. A powered muscle stimulator for rehabilitation is an
electrically powered device intended for medical purposes that
repeatedly contracts muscles by passing pulsed electrical current
through cutaneous electrodes contacting the affected body area. This
does not include the powered muscle stimulators classified in
paragraphs (b) through (d) of this section.
(2) Classification. Class II (special controls). The special
controls for this device are:
(i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Powered Muscle Stimulator for Rehabilitation.'' See
Sec. 890.1(e) for the availability of this guidance document; and
(ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter.
(b) Powered muscle stimulator with limited output for
rehabilitation--(1) Identification. A powered muscle stimulator with
limited output for rehabilitation is an electrically powered device
that is intended for medical purposes, and repeatedly contracts muscles
by passing pulsed electrical current through cutaneous electrodes
contacting the affected body area. This does not include the powered
muscle stimulators classified in paragraphs (a), (c), and (d) of this
section. The device utilizes a stimulus generator that delivers, into a
resistive load, which represents the worse case of either 500 ohms or
the typical load expected during normal conditions of use, the
following:
(i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is
[[Page 17099]]
the phase duration expressed in milliseconds and measured at 50 percent
of the phase amplitude);
(ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
(iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
(iv) An average direct current (dc) that does not exceed 100
microamperes when no pulses are being applied, or if the device fails;
(v) A maximum current density that does not exceed 2 milliamperes
root mean square (rms) per square centimeter of electrode conductive
surface area; and
(vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
(2) Classification. Class II (special controls). The special
controls for this device are:
(i) The FDA guidance document entitled ``Class II Special Controls
Guidance Document: Powered Muscle Stimulator with Limited Output for
Rehabilitation.'' See Sec. 890.1(e) for the availability of this
guidance document; and
(ii) Sale, distribution, and use are restricted to prescription use
in accordance with the prescription device requirements in Sec.
801.109 of this chapter. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations of exemptions in Sec. 890.9, when it
follows the recommendations of the special controls guidance and its
sale, distribution, and use are restricted to prescription use in
accordance with the prescription device requirements in Sec. 801.109
of this chapter.
(c) Powered muscle stimulator for muscle conditioning--(1)
Identification. A powered muscle stimulator for muscle conditioning is
an electrically powered device that repeatedly contracts muscles by
passing pulsed electrical current through cutaneous electrodes and into
the body, thereby temporarily affecting the stimulated muscles'
contractile properties, force output, and/or fatigue resistance. This
does not include the powered muscle stimulators classified in
paragraphs (a), (b), and (d) of this section.
(2) Classification. Class II (special controls.) The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Powered Muscle Stimulator for
Muscle Conditioning.'' See Sec. 890.1(e) for the availability of this
guidance document.
(d) Powered muscle stimulator with limited output for muscle
conditioning--(1) Identification. A powered muscle stimulator with
limited output for muscle conditioning is an electrically powered
device that repeatedly contracts muscles by passing pulsed electrical
current through cutaneous electrodes and into the body, thereby
temporarily affecting the stimulated muscles' contractile properties,
force output, and/or fatigue resistance. This does not include the
powered muscle stimulators classified in paragraphs (a) through (c) of
this section. The device utilizes a stimulus generator that delivers,
into a resistive load, which represents the worse case of either 500
ohms or the typical load expected during normal conditions of use, the
following:
(i) A maximum charge per phase that does not exceed Q, where Q = 20
+ (28)(t) microcoulombs (and where t is the phase duration expressed in
milliseconds and measured at 50 percent of the phase amplitude);
(ii) A maximum average current that does not exceed 10 milliamperes
(average absolute value);
(iii) A maximum primary (depolarizing) phase duration that does not
exceed 500 microseconds;
(iv) An average dc that does not exceed 100 microamperes when no
pulses are being applied, or if the device fails;
(v) A maximum current density that does not exceed 2 milliamperes
rms per square centimeter of electrode conductive surface area; and
(vi) A maximum average power density that does not exceed 0.25
watts per square centimeter of electrode conductive surface area.
(2) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Powered Muscle Stimulator with
Limited Output for Muscle Conditioning.'' See Sec. 890.1(e) for the
availability of this guidance document. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter, subject to the limitations of exemptions in Sec. 890.9, when
it follows the recommendations of the special controls guidance.
Dated: March 24, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-7637 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S