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