Document ID: FDA-2009-N-0493-0001
Agency: fda
Document Type: Proposed Rule
Title: Neurological and Physical Medicine Devices: Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification
Posted Date: 2010-04-05T04:00Z

[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Proposed Rules]               
[Page 17093-17099]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap10-25]                         

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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draft guidance documents that would serve as special controls for each 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: Robert.DeLuca@fda.hhs.gov, 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
----------------------------------------------------------------------------------------------------------------
                                                   No. of             No. of 510(k)s per
                Device Type                   Manufacturers\1\             Year\2\            Percentage Exempt
----------------------------------------------------------------------------------------------------------------
Electroconductive media                                       21                      0-5                   >90%
----------------------------------------------------------------------------------------------------------------
Cutaneous electrode                                           76                     5-15                   >90%
----------------------------------------------------------------------------------------------------------------
Transcutaneous electrical nerve stimulator                   110                    15-25                    60%
 for pain relief
----------------------------------------------------------------------------------------------------------------
Transcutaneous electrical stimulator for                       4                      0-5                    60%
 aesthetic purposes
----------------------------------------------------------------------------------------------------------------
Powered muscle stimulator for                                 81                    10-20                    50%
 rehabilitation
----------------------------------------------------------------------------------------------------------------
Powered muscle stimulator for muscle                          12                      0-8                    50%
 conditioning
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
                                                     No. of           No. of 510(k)s per
                 Device Type                    Manufacturers\1\            Year\2\           Percentage Exempt
----------------------------------------------------------------------------------------------------------------
Electroconductive media                                         21                     2.5                 > 90%
----------------------------------------------------------------------------------------------------------------
Cutaneous electrode                                             76                    10                   > 90%
----------------------------------------------------------------------------------------------------------------
Transcutaneous electrical nerve stimulator                     110                    20                     60%
 for pain relief
----------------------------------------------------------------------------------------------------------------
Transcutaneous electrical stimulator for                         4                     2.5                   60%
 aesthetic purposes
----------------------------------------------------------------------------------------------------------------

[[Page 17097]]

Powered muscle stimulator for rehabilitation                    81                    15                     50%
----------------------------------------------------------------------------------------------------------------
Powered muscle stimulator for muscle                            12                     4                     50%
 conditioning
----------------------------------------------------------------------------------------------------------------
\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