[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Rules and Regulations]
[Pages 6551-6553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2010-D-0645]


Medical Devices; General and Plastic Surgery Devices; 
Classification of Contact Cooling System for Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
contact cooling system for aesthetic use into class II (special 
controls). The special control that will apply to the device is the 
guidance document entitled ``Guidance for Industry and FDA Staff; Class 
II Special Controls Guidance Document: Contact Cooling System for 
Aesthetic Use.'' The Agency is classifying the device into class II 
(special controls) in order to provide reasonable assurance of safety 
and effectiveness of the device. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of a guidance document 
that will serve as the special control for this device type.

DATES: Effective Date: March 9, 2011.

FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1436, Silver Spring, MD 20993, 301-796-6392.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.) as amended by the Medical Device Amendments of 1976 (the 
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 
(Pub. L. 101-629), and the Food and Drug Administration Modernization 
Act (Pub. L. 107-250) established a comprehensive system for regulation 
of medical devices intended for human use. Section 513 of the FD&C 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).
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976 (the date of enactment of the 1976 amendments), as 
postamendments devices. Postamendments devices are classified 
automatically by statute (section 513(f) of the FD&C Act) into class 
III without any FDA rulemaking process. These devices remain in class 
III and require premarket approval unless: (1) FDA reclassifies the 
device into class I or II; (2) FDA issues an order classifying the 
device into class I or class II in accordance with section 513(f)(2) of 
the FD&C Act; or FDA issues an order finding the device to be 
substantially equivalent, under section 513(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 FD&C Act (21 
U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    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 that has not 
previously been classified into class III under section 513(f)(1), 
request FDA to classify the device under the criteria set forth in 
section 513(a)(1). FDA will, within 60 days of receiving this request, 
classify the device by written order. This classification shall be the 
initial classification of the device. Within 30 days after the issuance 
of an order classifying the device, FDA must publish a notice in the 
Federal Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on October 7, 2009, classifying the Zeltiq Lipolysis System for 
Aesthetic Use 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 which was subsequently reclassified 
into class I or class II. On October 13, 2009, Zeltiq\TM\ Aesthetic, 
Inc., submitted a petition requesting classification of the lipolysis 
system for aesthetic use under section 513(f)(2) of the FD&C Act. 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 section 513(a)(1). FDA classifies devices 
into class II if general controls by themselves are insufficient 
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 contact cooling system for aesthetic 
use can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide assurance of 
the safety and effectiveness of the device.
    The device was assigned the generic name ``Cooling System for 
Aesthetic Use'' and it is identified as a cooling system for aesthetic 
use. FDA has identified the following risks to health associated 
specifically with this type of device and the recommended measures to 
mitigate these risks.
     Discomfort and pain during and following treatment are 
possible due to the application of mechanical or vacuum massage at 
levels in excess of those recommended in the labeling. These effects 
and tenderness at the treatment site may also occur following 
treatment. Prevention of these effects are addressed by adequate bench 
testing demonstrating that the feedback controls for temperature/
cooling are functional and do maintain target temperature within the 
stated value. Proper function of mechanical controls to insure use of 
the mechanical or vacuum massager within safe limits

[[Page 6552]]

should be confirmed as part of bench testing.
     Electrical shock is addressed by recommended testing of 
the device according to recognized U.S. and International Standards 
specifically designed to determine and measure potential electrical 
safety. Again, the recommended device labeling also includes specific 
warnings for the user in terms of device placement, appropriate 
electrical wiring needs, reminders to periodically check device wiring 
and accessories for damage, and avoidance of use of the device in 
environments where electrical shock is possible.
     Use error represents those risks to the patient that can 
occur from improper use of the device. In order to address this 
potential risk, we recommend the manufacturer provide a detailed 
operator manual which contains information on possible risks and 
hazards and how these should be avoided and clear recommended safe 
treatment procedures that include information on device settings for 
treatment, clear information on how the device is to be used during 
treatment, and recommended post treatment care.
     Tissue damage from uncontrolled cooling is a risk which is 
addressed by the above stated bench testing of the temperature control 
system. In addition the labeling provided shall give recommended safe 
use parameters in terms of temperature setting and duration of 
treatment with these parameters supported by animal or clinical data.
     Systemic response to cold is a potential hazard for 
individuals who may have underlying cold sensitive health conditions or 
reduced skin sensitivity due to other medical conditions. This risk is 
addressed through the device labeling which provides appropriate 
cautions, warnings and contradictions for such cold sensitive 
conditions.
     Skin inflammation or foreign body responses can be an 
issue for individuals based on the skin contact nature of this device. 
This type of skin irritation is prevented by appropriate testing for 
biocompatibility of the contact materials when in contact with skin.

            Table 1--Risks to Health and Mitigation Measures
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            Identified risk              Recommended mitigation measures
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Discomfort, Pain, Tenderness...........  Section 6. Bench Testing
                                         Section 9. Clinical Testing
                                         Section 13. Labeling
Thermal Injury (Tissue Damage from       Section 6. Bench Testing
 Uncontrolled Cooling).                  Section 7. Software Validation
                                         Section 8. Animal Testing
                                         Section 9. Clinical Testing
                                         Section 11. Electromagnetic
                                          Compatibility (IEC 60601-1-2)
                                         Section 13. Labeling
Systemic Response to Cold..............  Section 9. Clinical Testing
                                         Section 13. Labeling
Electrical Shock.......................  Section 12. Electrical and
                                          Mechanical Safety (IEC 60601-
                                          1)
Inflammation/Foreign Body Response.....  Section 10. Biocompatibility
                                          (ISO 10993)
Use Error..............................  Section 13. Labeling
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    FDA believes that the special controls, in addition to general 
controls, address the risks to health identified in table 1 of this 
document and provide reasonable assurance of the safety and 
effectiveness of the device type. Therefore, on August 24, 2010, FDA 
issued an order to the petitioner classifying the device into class II. 
FDA is codifying this device classification by adding 21 CFR 878.4340.
    Following the effective date of the final classification rule, any 
firm submitting a 510(k) premarket notification for cooling system for 
aesthetic use device intended for the disruption of adipocyte cells 
intended for non-invasive aesthetic use will need to address the issues 
covered in the special controls guidance. However, the firm 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 cooling system for aesthetic use that 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. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the analysis of impacts of this rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 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 final 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. Because reclassification of this device from class 
III to class II will relieve manufacturers of the cost of complying 
with the premarket approval requirements of section 515 of the FD&C

[[Page 6553]]

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 $135 million, using the most current (2009) 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 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, 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 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?

    This final rule contains no collections of new information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 is not required. Elsewhere in this 
issue of the Federal Register, FDA is issuing a notice announcing 
availability of the guidance for the final rule. This guidance entitled 
``Class II Special Controls Guidance Document: Contact Cooling System 
for Aesthetic Use'' references previously approved collections of 
information found in FDA regulations.

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 Zeltiq Aesthetics, October 13, 2009.

List of Subjects in 21 CFR Part 878

    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 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

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

0
2. Section 878.4340 is added to subpart E to read as follows:


Sec.  878.4340  Contact cooling system for aesthetic use.

    (a) Identification. A contact cooling system for aesthetic use is a 
device that is a combination of a cooling pad associated with a vacuum 
or mechanical massager intended for the disruption of adipocyte cells 
intended for non-invasive aesthetic use.
    (b) Classification. Class II (special controls). The special 
controls for this device is FDA's ``Guidance for Industry and FDA 
Staff; Class II Special Controls Guidance Document: Contact Cooling 
System for Aesthetic Use.'' See Sec.  878.1(e) for the availability of 
this guidance document.

    Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2552 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P