
[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Rules and Regulations]
[Pages 51876-51878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2011-M-0570]


Medical Devices; Ophthalmic Devices; Classification of the Eyelid 
Thermal Pulsation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
eyelid thermal pulsation system into class II (special controls). 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.

DATES: This rule is effective September 19, 2011. The classification 
was effective on June 28, 2011.

FOR FURTHER INFORMATION CONTACT: Marc Robboy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2256, Silver Spring, MD 20993-0002, 301-796-6860.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (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 (21 U.S.C. 360c(i)), to a predicate 
device that does not require premarket approval. The Agency determines 
whether new devices are substantially equivalent to predicate devices 
by means of premarket notification procedures in section 510(k) of the 
FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR 
part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device 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 July 12, 2010, classifying the LipiFlow[supreg] Thermal 
Pulsation System 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 August 6, 2010, TearScience, Inc., 
submitted a petition requesting classification of the LipiFlow[supreg] 
Thermal Pulsation System 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 eyelid thermal pulsation 
system, and it is identified as an electrically-powered device intended 
for use in the application of localized heat and pressure therapy to 
the eyelids. The device is used in adult patients with chronic cystic 
conditions of the eyelids,

[[Page 51877]]

including meibomian gland dysfunction (MGD), also known as evaporative 
dry eye or lipid deficiency dry eye. The system consists of a component 
that is inserted around the eyelids and a component to control the 
application of heat and pressure to the eyelids.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility and Shelf Life
                                             Testing.
Adverse tissue reaction...................  Biocompatibility.
Electrical shock..........................  Electrical Safety Testing.
Electromagnetic interference..............  Electromagnetic
                                             Compatibility (EMC)
                                             Testing; Labeling.
Thermal damage............................  Temperature Performance
                                             Testing.
Mechanical damage.........................  Pressure Performance
                                             Testing.
Malfunction...............................  Non-clinical and Clinical
                                             Performance Testing.
User error................................  Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls can address these 
risks to health and provide reasonable assurance of safety and 
effectiveness: (1) Appropriate analysis/testing should validate 
electromagnetic compatibility (EMC) and safety of exposure to non-
ionizing radiation; (2) Design, description, and performance data 
should validate safeguards related to the temperature and pressure 
aspects of the device, including during fault conditions; (3) 
Performance data should demonstrate the sterility of patient-contacting 
components and the shelf-life of these components; (4) The device 
should be demonstrated to be biocompatible; and (5) Performance data 
should demonstrate that any technological changes do not adversely 
affect safety and effectiveness. Therefore, on June 28, 2011, FDA 
issued an order to the petitioner classifying the device into class II. 
FDA is codifying the classification of the device by adding Sec.  
886.5200.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for an eyelid thermal 
pulsation system will need to comply with the special controls named in 
the regulation.
    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 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 eyelid thermal pulsation system 
they intend to market.

II. 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.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because 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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Federalism

    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) Medtronic Inc., v. Lohr, 
518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008)). 
The special controls established by this final rule 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. See Papike v. Tambrands, Inc., 107 F. 3d 737, 740-
42 (9th Cir. 1997).

V. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to 
currently approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 32501-3520). The collections of information in 
21 CFR part 807, supbart E, have been approved under OMB control number 
0910-0120; the collections of information in 21 CFR part 801 have been 
approved under OMB control number 0910-0485.

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

[[Page 51878]]

between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from TearScience, Inc., August 6, 2010.

List of Subjects in 21 CFR Part 886

    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 
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as 
follows:

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


0
2. Section 886.5200 is added to subpart F to read as follows:


Sec.  886.5200  Eyelid thermal pulsation system.

    (a) Identification. An eyelid thermal pulsation system is an 
electrically-powered device intended for use in the application of 
localized heat and pressure therapy to the eyelids. The device is used 
in adult patients with chronic cystic conditions of the eyelids, 
including meibomian gland dysfunction (MGD), also known as evaporative 
dry eye or lipid deficiency dry eye. The system consists of a component 
that is inserted around the eyelids and a component to control the 
application of heat and pressure to the eyelids.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing should validate electromagnetic 
compatibility (EMC) and safety of exposure to non-ionizing radiation;
    (2) Design, description, and performance data should validate 
safeguards related to the temperature and pressure aspects of the 
device, including during fault conditions;
    (3) Performance data should demonstrate the sterility of patient-
contacting components and the shelf-life of these components;
    (4) The device should be demonstrated to be biocompatible; and
    (5) Performance data should demonstrate that any technological 
changes do not adversely effect safety and effectiveness.

    Dated: August 12, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-21195 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P


