20840 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Rules and Regulations 

12Order No. 717, FERC Stats. & Regs ¶ 31,280 at 

P 151. 

13Order No. 717 specifically recognized that there 

are employees who are neither transmission 

function employees nor marketing function 

employees. See, e.g., Order No. 717, FERC Stats. & 

Regs. ¶ 31,280 at P 174 (‘‘Transmission function 

employees are no longer barred from interacting 

with all the employees of a marketing or energy 

affiliate (only marketing function employees)’’). 

14See Standards of Conduct for Transmission 

Providers, Order No. 717–A, 74 FR 54463 (Oct. 22, 

2009), FERC Stats. & Regs. ¶ 31,297, at P 27 (2009). 

interconnection-related system impact 

studies. 

10. Similarly, we deny TAPS’s request 

that the information from system impact 

studies be made available on a nondiscriminatory basis to all interested 

transmission customers. TAPS 

erroneously assumes that the 

Commission determined that system 

impact studies (or other studies) 

performed in response to 

interconnection requests are planning 

activities that may be conducted by 

marketing function employees. 

Marketing function employees may not 

perform system impact studies (or other 

studies) in response to interconnection 

requests since the studies would involve 

the use and analysis of non-public 

transmission information. As we stated 

in Order No. 717, planning personnel 

who do not qualify as marketing 

function employees may discuss 

information with transmission function 

employees.12 However, we reiterated 

that the No Conduit Rule applied in this 

situation, stating that if transmission 

employees share transmission function 

information with planning personnel, 

the planning personnel may not pass 

such information on to marketing 

function employees. The clear 

implication of these statements is that 

while planning studies may be 

conducted by personnel who are not 

transmission function employees, 

marketing function employees may not 

participate in the preparation of studies 

which involve the use and analysis of 

non-public transmission information.13

11. We grant TAPS’s clarification 

request that when an employee 

performs a system impact study in 

response to a transmission service 

request, that employee is a transmission 

function employee regardless of the 

duration of the requested transmission 

service. This clarification is consistent 

with our previous conclusion that the 

designation of an employee as a 

transmission function employee does 

not depend upon the duration of the 

requested transmission service.14

III. Document Availability 

12. In addition to publishing the full 

text of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the Internet through 

FERC’s Home Page (http://www.ferc.gov) 

and in FERC’s Public Reference Room 

during normal business hours (8:30 a.m. 

to 5 p.m. Eastern time) at 888 First 

Street, NE., Room 2A, Washington, DC 

20426. 

13. From FERC’s Home Page on the 

Internet, this information is available on 

eLibrary. The full text of this document 

is available on eLibrary in PDF and 

Microsoft Word format for viewing, 

printing, and/or downloading. To access 

this document in eLibrary, type the 

docket number excluding the last three 

digits of this document in the docket 

number field. 

14. User assistance is available for 

eLibrary and the FERC’s website during 

normal business hours from FERC 

Online Support at 202–502–6652 (toll 

free at 1–866–208–3676) or e-mail at 

ferconlinesupport@ferc.gov, or the 

Public Reference Room at (202) 502– 

8371, TTY (202) 502–8659. E-mail the 

Public Reference Room at 

public.referenceroom@ferc.gov. 

IV. Effective Date 

15. Changes to Order No. 717–C 

adopted in this order on rehearing and 

clarification are effective May 16, 2011. 

By the Commission. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2011–9059 Filed 4–13–11; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2011–N–0188] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Low Level Laser System for Aesthetic 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

low level laser system for aesthetic use 

into class II (special controls). The 

special control(s) that will apply to the 

device is entitled ‘‘Class II Special 

Controls Guidance Document: Low 

Level Laser System for Aesthetic Use.’’ 

The Agency is classifying the device 

into class II (special controls) in order 

to provide a 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: This rule is effective May 16, 

2011. The classification was effective on 

August 24, 2010. 

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 20993–0002, 301–796–6392. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

rulemaking? 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and 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 into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will 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 

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Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Rules and Regulations 20841 

December 22, 2008, classifying the 

Erchonia Low Level Laser 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 January 5, 2009, 

Erchonia, Inc., submitted a petition 

requesting classification of the Erchonia 

Low Level Laser 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) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name Low Level Laser System for 

Aesthetic Use, and it is identified as a 

device using low level laser energy for 

the disruption of adipocyte cells within 

the fat layer for the release of fat and 

lipids from these cells for noninvasive 

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. 

• Ocular injury is a recognized hazard 

from laser optical systems because of 

the unique physical characteristics of 

laser light; that is, this optical radiation 

is easily transmitted into the eye as a 

very bright, intense light beam that may 

produce lesions on the retina. This 

hazard is addressed by device labeling, 

which includes recommendations for 

not looking directly at the laser beam 

and the wearing of appropriate laser 

safety eyewear by both the user and 

patient. The labeling also includes 

information defining the size of the area 

within which this optical hazard exists. 

• 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. 

• Unintended cell damage is a 

potential risk from use of low level 

lasers if improper or incorrect energy is 

used to initiate the process of causing 

lipid and fat leakage from the target 

adipocyte cells. The intended effect on 

the adipocyte cells is the creation of 

pores that results in the lipid or fat 

leaving these specialized cells; however, 

if the laser parameters are not correct, 

no effect may occur in terms of 

adipocyte change or other nonadipocyte cells may be affected, 

resulting in alteration of other cellular 

membranes or transport systems that 

could result in unintended cell death. 

• 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 posttreatment care. 

FDA believes that the class II special 

controls guidance document will aid in 

mitigating the potential risks to health 

as described in table 1 of this document. 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES

Identified risk Recommended mitigation measures 

Ocular Injury ............................................................................................. Section 6. Bench Testing. 

Section 7. Software Validation. 

Section 8. Clinical Testing. 

Section 12. Labeling. 

Electrical Shock ........................................................................................ Section 11. Electrical and Mechanical Safety Performance Testing (IEC 

60601–1). 

Section 12. Labeling. 

Unintended Cell Damage ......................................................................... Section 6. Bench Testing. 

Section 7. Software Validation. 

Section 8. Clinical Testing. 

Section 9. Biocompatibility. 

Section 10. Electromagnetic Compatibility (IEC 60601–1–2). 

Section 12. Labeling. 

Use Error .................................................................................................. Section 12. Labeling. 

FDA believes that the special controls 

guidance, ‘‘Low Level Laser System for 

Aesthetic Use,’’ in addition to general 

controls, address the risks to health and 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on August 24, 2010, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 878.5400. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for low level laser system 

for 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 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

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20842 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Rules and Regulations 

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. Therefore, this device 

type 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 low level laser system for 

aesthetic use 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 

and 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 and so 

it is not subject to review under 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 device of 

the cost of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the Agency 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $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 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. (See 

section 521 of the FD&C Act (21 U.S.C. 

360k); See Medtronic, Inc., v. Lohr, 518 

U.S. 470 (1996); and Riegel v. 

Medtronic, Inc., 128 S. Ct. 999 (2008)). 

The special controls established by this 

final rule creates ‘‘requirements’’ for 

specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements. (See 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997)). 

V. How does this rule comply with the 

Paperwork Reduction Act of 1995? 

FDA concludes that this final rule 

contains no new collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3520) is not required. This final rule 

establishes as special controls a 

guidance document that refers to 

previously approved collections of 

information found in other FDA 

regulations. These collections of 

information are subject to review by 

OMB under the PRA. Elsewhere in this 

issue of the Federal Register, FDA is 

issuing a notice announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Low Level Laser 

System for Aesthetic Use’’ that will 

serve as the special control for this 

device. This notice contains an analysis 

of the paperwork burden for the 

guidance document. 

VI. References 

The following references have 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 Erchonia, Inc., 

January 5, 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 

■ 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. 

■ 2. Section 878.5400 is added to 

subpart F to read as follows: 

§ 878.5400 Low Level Laser System for 

Aesthetic Use 

(a) Identification. A Low Level Laser 

System for Aesthetic Use is a device 

using low level laser energy for the 

disruption of adipocyte cells within the 

fat layer for the release of fat and lipids 

from these cells for noninvasive 

aesthetic use. 

(b) Classification. Class II (special 

controls). The special control for this 

device is the FDA guidance document 

entitled ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

Class II Special Controls Guidance 

Document: Low Level Laser System for 

Aesthetic Use.’’ See § 878.1(e) for the 

availability of this guidance document. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8944 Filed 4–13–11; 8:45 am] 

BILLING CODE 4160–01–P 

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