Document ID: FDA-2013-N-0069-0001
Agency: fda
Document Type: Proposed Rule
Title: Medical Devices; Ophthalmic Devices: Classification of the Eyelid Weight
Posted Date: 2013-02-08T05:00Z

[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Proposed Rules]
[Pages 9349-9353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02862]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2013-N-0069]

Medical Devices; Ophthalmic Devices; Classification of the Eyelid 
Weight

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify the eyelid weight into class II (special controls). The eyelid 
weight may be adhered to the outer skin of the upper eyelid (external 
eyelid weight) or implanted into the upper eyelid (implantable eyelid 
weight), and is intended for the gravity assisted treatment of 
lagophthalmos (incomplete eyelid closure). FDA is also giving notice of 
its intent to exempt the external eyelid weight device from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). After considering public comments on the 
proposed classification, FDA will publish a final regulation 
classifying this device type.

DATES: Submit either electronic or written comments by May 9, 2013. See 
section IV of this document for the proposed effective date of a final 
rule that may issue based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0069, 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 way:
     Mail/Hand delivery/Courier (for paper 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 received must include the Agency name 
and Docket No. FDA-2013-N-0069 for this rulemaking. All comments 
received may 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: Tina Kiang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 2414, Silver Spring, MD 20993-0002, 301-796-6860, 
Tina.Kiang@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Statutory and Regulatory Authorities

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical 
Device Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices 
Act of 1990 (Pub. L. 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115), among other amendments, 
established a comprehensive system for the 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

[[Page 9350]]

devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the FD&C Act, FDA refers to devices that were 
in commercial distribution before May 28, 1976 (the date of enactment 
of the Medical Device Amendments of 1976), as ``preamendments 
devices.'' FDA classifies these devices after the Agency takes the 
following steps:
     Receives a recommendation from a device classification 
panel (an FDA advisory committee);
     Publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and
     Publishes a final regulation classifying the device.

FDA has classified most preamendments devices under these procedures.
    A person may market a preamendments device that has been classified 
into class III through premarket notification procedures, without 
submission of a premarket approval application until FDA publishes a 
final regulation under section 515(b) of the FD&C Act (21 U.S.C. 
360e(b)) requiring premarket approval.
    Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that a 
class II device may be exempted from the premarket notification 
requirements under section 510(k) of the FD&C Act, if the Agency 
determines that premarket notification is not necessary to assure the 
safety and effectiveness of the device. FDA has determined that 
premarket notification is not necessary to assure the safety and 
effectiveness of the external eyelid weight.

B. Regulatory History of the Device

    After the enactment of the Medical Device Amendments of 1976, FDA 
commenced to identify and classify all preamendments devices, in 
accordance with section 513(b) of the FD&C Act. In the Federal Register 
of September 2, 1987 (52 FR 33346), FDA classified a total of 109 
generic types of ophthalmic devices. The eyelid weight was not 
identified in this initial effort. FDA has regulated eyelid weights as 
devices requiring premarket notification (section 510(k) of the FD&C 
Act). Eyelid weights currently on the market have been determined to be 
substantially equivalent to devices that were in commercial 
distribution prior to May 28, 1976.
    Consistent with the FD&C Act and the regulations, FDA consulted 
with the Ophthalmic Devices Panel (the Panel), an FDA advisory 
committee, regarding the classification of this device type on January 
13 and 14, 2000 (Ref. 1).

II. Panel Recommendation

A. Identification

    An eyelid weight is a prescription device made of gold, tantalum, 
platinum, iridium, or surgical grade stainless steel that is 
rectangular in shape and contoured to the shape of the eye. The device 
is intended for the gravity assisted treatment of lagophthalmos 
(incomplete eyelid closure). The external eyelid weight is adhered to 
the outer skin of the upper eyelid. The implantable eyelid weight is 
implanted into the upper eyelid.

B. Recommended Classification of the Panel

    The Panel recommended that the eyelid weight, both external and 
implantable, be classified into class II. The Panel also recommended 
that the external eyelid weight be exempt from premarket notification 
requirements. The Panel believed that class II classification (with 
special controls appropriate for the external eyelid weight and special 
controls appropriate for the implantable eyelid weight) would provide 
reasonable assurance of the safety and effectiveness of the device.

C. Summary of Reasons To Support the Proposed Panel Recommendation

    The Panel considered information from the scientific literature 
review conducted by FDA, FDA's extensive regulatory experience with the 
device type, and the Panel members' personal knowledge of and clinical 
experience with the device type. The Panel also considered the long 
history of safety and effectiveness of the device, both external and 
implantable, over many years of clinical use. The Panel recommended 
that the eyelid weight, external and implantable, be classified into 
class II because the Panel concluded that special controls, in addition 
to general controls, would provide reasonable assurance of the safety 
and effectiveness of the device type, and that there is sufficient 
information to establish special controls to provide such assurance for 
both the external and implantable eyelid weight. The Panel also 
recommended that the external eyelid weight be exempt from premarket 
notification requirements, while the implantable eyelid weight would 
not be exempt from premarket notification.

D. Risks to Health and Special Controls

    Based on the Panel's discussion and recommendations and FDA's 
experience with the device, the risks to health associated with the 
external eyelid weight and the proposed measures to mitigate these 
risks are identified in table 1 of this document; the risks to health 
associated with the implantable eyelid weight and the proposed measures 
to mitigate these risks are identified in table 2 of this document.

                  Table 1--Health Risks and Mitigation Measures for the External Eyelid Weight
----------------------------------------------------------------------------------------------------------------
                Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Mild adverse tissue reaction...................  Biocompatibility testing and labeling.
Magnetic resonance (MR) incompatibility........  Nonclinical testing and labeling.
Temporary induced astigmatism (which can result  Labeling.
 in blurred vision requiring glasses).
Ptosis (droopy eyelid).........................  Labeling.
----------------------------------------------------------------------------------------------------------------

Risks associated with the use of the external eyelid weight are related 
to the placement of the device and the material of which it is 
composed. Biocompatibility testing will mitigate the risk of mild 
adverse tissue reaction; nonclinical testing will mitigate the risk of 
MR incompatibility; labeling will mitigate the risks of mild adverse 
tissue reaction, temporary induced astigmatism, and ptosis, and 
communicate potential MR incompatibility.
    FDA believes that the following special controls, in addition to 
general controls, can address the risks to health in table 1 of this 
document and provide reasonable assurance of safety and effectiveness 
of the device: (1) Testing demonstrating the biocompatibility of the 
device; (2) and nonclinical testing evaluating the compatibility of the 
device in a MR environment. In addition, under 21 CFR 801.109, the 
sale, distribution, and use of the device are restricted to 
prescription use.

[[Page 9351]]

                 Table 2--Health Risks and Mitigation Measures for the Implantable Eyelid Weight
----------------------------------------------------------------------------------------------------------------
               Identified risk                                        Mitigation measures
----------------------------------------------------------------------------------------------------------------
Adverse tissue reaction.....................  Biocompatibility testing and labeling.
Device migration............................  Biocompatibility testing and labeling.
Extrusion through the eyelid................  Biocompatibility testing and labeling.
Infection...................................  Sterility testing.
MR incompatibility..........................  Nonclinical testing and patient labeling.
Induced astigmatism (which can result in      Labeling.
 blurred vision requiring glasses).
Ptosis......................................  Labeling.
----------------------------------------------------------------------------------------------------------------

    There are additional risks for the implantable eyelid weight, 
related to the more invasive position of the device, which include 
infection, device migration, and extrusion through the eyelid. In 
addition to special controls regarding biocompatibility testing and 
nonclinical testing for MR compatibility and labeling special controls, 
FDA is proposing special controls for the implantable eyelid weight 
addressing sterility and patient labeling. Biocompatibility testing 
will mitigate the risk of adverse tissue reaction, device migration, 
and extrusion through the eyelid. Sterility testing will mitigate the 
risk of infection. Nonclinical testing will mitigate the risk of MR 
incompatibility. Patient labeling will communicate potential MR 
incompatibility or the conditions for safe use in an MR environment. 
Labeling will mitigate the risk of adverse tissue reaction, device 
migration, extrusion through the eyelid, induced astigmatism, and 
ptosis.
    FDA believes that the following special controls, in addition to 
general controls, will address the risks to health in table 2 of this 
document and provide reasonable assurance of safety and effectiveness 
of the implantable eyelid weight: (1) Testing demonstrating the 
biocompatibility of the device; (2) testing demonstrating the sterility 
and shelf life of the device; (3) nonclinical testing evaluating the 
compatibility of the device in an MR environment; and (4) patient 
labeling to convey information regarding the safety and compatibility 
of the device in an MR environment, the conditions under which a 
patient with the device can be safely scanned, and a mechanism for a 
healthcare provider to obtain detailed information about MR safety and 
compatibility if needed. In addition, under Sec.  801.109, the sale, 
distribution, and use of the device are restricted to prescription use.

III. Proposed Classification and FDA's Findings

    To better inform the Agency's proposed classification of the eyelid 
weight device type as described in this proposed rule, FDA conducted a 
review of the literature that included relevant scientific and medical 
information published through 2011 (see representative articles in 
Refs. 2 through 20). FDA has received no reports of adverse events 
related to external or implantable eyelid weights. Based upon this 
updated review of the literature and FDA's continued premarket and 
postmarket experience with the device type, FDA agrees with the Panel's 
recommendation that the eyelid weight be classified into class II. FDA 
believes that special controls for both the external and implantable 
eyelid weight, in addition to general controls, would provide 
reasonable assurance of the safety and effectiveness of the device, and 
there is sufficient information to establish special controls to 
provide such assurance. FDA also agrees with the Panel's recommendation 
that premarket notification is not necessary to assure the safety and 
effectiveness of the external eyelid weight and, therefore, the Agency 
is giving notice of intent to exempt the external eyelid weight device 
from premarket notification requirements.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal 
become effective 30 days after its date of publication in the Federal 
Register.

V. 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.

VI. Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed 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 (Public 
Law 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 proposed rule is not a 
significant regulatory action as defined by 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 classifying these devices as class II will 
relieve manufacturers of external eyelid weights of the cost of 
complying with the premarket notification requirements of section 515 
of the FD&C Act, and may permit small potential competitors to enter 
the marketplace by lowering costs, the Agency certifies that the 
proposed 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 $139 million, using the most current (2011) 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.

B. Summary

    The proposed rule would exempt manufacturers of external eyelid 
weights from submitting a premarket notification, provided they meet 
certain special controls. Manufacturers of implantable eyelid weights 
would still be required to submit a premarket

[[Page 9352]]

notification and meet certain special controls. Because the proposed 
special controls are similar to those in place currently, we do not 
expect there to be any new costs to society. FDA has concluded that 
maintaining current controls will place no additional costs on 
producers and that meeting these special controls provides reasonable 
assurance that the devices are safe and effective. The special controls 
are not expected to pose new risks, and thus costs, to public health.
    Adopting the proposed rule is expected to benefit society by 
removing the costs associated with preparing, reviewing, and responding 
to premarket notifications for manufacturers of external eyelid 
weights. We estimate the annual costs savings to be $3,438. Over 20 
years, the estimated present discounted value of the savings ranges 
from $28,746, at a 3-percent discount rate, to $20,470 at a 7-percent 
discount rate.

C. Preliminary Regulatory Impact Analysis

1. Benefits
    Adopting the proposed rule would exempt manufacturers of external 
eyelid weights from submitting premarket notification, resulting in 
cost savings that are approximately equal to the expenses necessary to 
prepare, review, and respond to premarket notifications. To calculate 
these expenses, we multiply the average value of resources necessary to 
prepare, review, and respond to premarket notifications by the annual 
reduction in time spent working on these reports [= (the average cost 
to prepare, review, and respond to a premarket notification) * (annual 
reduction in number of premarket notifications for external eyelid 
weights)].
    In the past decade, FDA has received one premarket notification 
related to external eyelid weights. The Agency expects this trend to 
remain relatively stable over time, and thus projects that implementing 
the proposed rule would result in an average annual reduction of 0.1 
premarket notifications (= 1/10).
    The average cost to prepare a premarket notification roughly equals 
the average number of pages per report multiplied by the average cost 
to prepare one page. FDA reviewers indicate that, in the last decade 
the average premarket notification on external eyelid weights is 
approximately 91 pages long. Blozan and Tucker (Ref. 21) indicates that 
it costs approximately $500, on average, to prepare a premarket 
notification that is roughly 24 pages long. This estimate indicates 
that the average cost to prepare one page is $21 (= $500/24). Updated 
to 2011 dollars, per page costs roughly equal $37.78 (Ref. 22). Given 
these measures, we estimate the average cost to prepare a premarket 
notification is approximately $3,438 (= 91 * $37.78).
    The average cost to review one premarket notification was 
approximately $13,400 in 2004 (Ref. 23). Updated to 2001 dollars, this 
cost roughly equals $15,695 per premarket notification. Finally, most 
responses to premarket notifications are 5 pages long. Given that the 
cost to prepare one page is roughly $37.78, we estimate that the 
average cost to respond to a premarket notification roughly equals $189 
(= 5 * $37.78).
2. Summary and Discussion
    The proposed rule is expected to provide modest cost savings to 
society. We estimate that implementing the proposed rule is expected to 
result in an average annual cost savings equal to $1932 (= [0.1 reports 
per year] * [$3438 + $15,695 + $189]). Over 20 years, the estimated 
present value of the savings is $28,746, at a 3-percent discount rate, 
and $20,470, at a 7-percent discount rate.

D. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires Agencies to prepare a 
regulatory flexibility analysis if a proposed rule would have a 
significant effect on a substantial number of small businesses, non-
profit organizations, local jurisdictions, or other entities. The 
proposed rule would exempt manufacturers of external eyelid weights 
from submitting a premarket notification. We expect this exemption to 
modestly reduce costs associated with gaining premarket approval, and 
thus certify that the proposed rule would not significantly affect a 
substantial number of small businesses, non-profit organizations, local 
jurisdictions, or other entities.

VII. Paperwork Reduction Act of 1995

    This proposed 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. 3501-3520). The collections of information in 21 
CFR part 807, subpart 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.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

1. Transcript from the Food and Drug Administration Ophthalmic 
Devices Panel Meeting, January 13 and 14, 2000.
2. Seiff, S. R., M. Boerner, and S. R. Carter, ``Treatment of Facial 
Palsies With External Eyelid Weights,'' American Journal of 
Ophthalmology, vol. 120, no. 5, pp 652-657, November 1995.
3. Neuman, A. R., A. Weinberg, M. Sela, I. J. Peled, and M. R. 
Wexler, ``The Correction of Seventh Nerve Palsy Lagophthalmos With 
Gold Lid Load (16 Years Experience),'' Annals of Plastic Surgery, 
vol. 22, no. 2, pp. 142-145, February 1989.
4. Kelley, S. A. and D. T. Sharpe, ``Gold Eyelid Weights in Patients 
With Facial Palsy: A Patient Review,'' Plastic and Reconstructive 
Surgery, vol. 89, no. 3, pp. 436-440, March 1992.
5. Jobe, R., ``Gold Lid Loads,'' Plastic and Reconstructive Surgery, 
vol. 91, no. 3, pp. 563-564, March 1993.
6. Pickford, M. A., T. Scamp, and D. H. Harrison, ``Morbidity After 
Gold Weight Insertion Into the Upper Eyelid in Facial Palsy,'' 
British Journal of Plastic Surgery, vol. 45, no. 6, pp. 460-464, 
August-September 1992.
7. Patel, B. C., P. Flaharty, and R. L. Anderson, ``Morbidity After 
Gold Weight Insertion,'' British Journal of Plastic Surgery, vol. 
46, no. 4, pp. 343-344, June 1993.
8. Jobe, R., ``The Use of Gold Weights in the Upper Eyelid,'' 
British Journal of Plastic Surgery, vol. 46, no. 4, pp. 343-344, 
June 1993.
9. Chapman, P. and B. G. Lamberty, ``Results of Upper Lid Loading in 
the Treatment of Lagophthalmos Caused by Facial Palsy,'' British 
Journal of Plastic Surgery, vol. 41 no. 4, pp. 369-372, July 1988.

[[Page 9353]]

10. Seiff, S. R., J. H. Sullivan, L. N. Freeman, and J. Ahn, 
``Pretarsal Fixation of Gold Weights in Facial Nerve Palsy,'' 
Ophthalmic Plastic and Reconstructive Surgery, vol. 5, no. 2, pp. 
104-109, 1989.
11. Kartush, J. M., C. J. Linstrom, P. M. McCann, and M. D. Graham, 
``Early Gold Weight Eyelid Implantation for Facial Paralysis,'' 
Otolaryngology--Head and Neck Surgery, vol. 103, no. 6, pp. 1016-
1023, December 1990.
12. Townsend, D. J., ``Eyelid Reanimation for the Treatment of 
Paralytic Lagophthalmos: Historical Perspectives and Current 
Applications of the Gold Weight Implant,'' Ophthalmic Plastic and 
Reconstructive Surgery, vol. 8, no. 3, pp. 196-201, 1992.
13. Silver, A. L., R. W. Lindsay, M. L. Cheney, and T. A. Hadlock, 
``Thin-Profile Platinum Eyelid Weighting: A Superior Option in the 
Paralyzed Eye,'' Plastic and Reconstructive Surgery, vol. 123, no. 
6, pp. 1697-1703, June 2009.
14. Schrom, T., A. Loch, M. H[ouml]lzl, and H. Scherer, Abstract: 
``Evaluation of a New Lid Implant for Rehabilitation of the 
Paralyzed Eye,'' Laryngorhinootologie, vol. 85, no. 1, pp. 38-42, 
January 2006.
15. Zwick, O. M. and S. R. Seiff, ``Supportive Care of Facial Nerve 
Palsy with Temporary External Eyelid Weights,'' Optometry, vol. 77, 
no. 7, pp. 340-342, July 2006.
16. Williams, Z. R. and J. V. Aquavella, ``Management of Exposure 
Keratopathy Associated with Severe Craniofacial Trauma,'' Journal of 
Cataract and Refractive Surgery, vol. 33, no. 9, pp. 1647-1650, 
September 2007.
17. Gautam, P, R. K. Adhikari, and B. R. Sharma, ``A Profile of Eye-
Lid Conditions Requiring Reconstruction Among the Patients Attending 
an Oculoplasty Clinic in Mid-Western Region of Nepal,'' Nepalese 
Journal of Ophthalmology, vol. 3, no. 5, pp. 49-51, January 2011.
18. Heier, J. S., R. W. Enzenauer, S. F. Wintermeyer, M. Delaney, 
and F. P. LaPiana, ``Ocular Injuries and Diseases at a Combat 
Support Hospital in Support of Operations Desert Shield and Desert 
Storm,'' Archives of Ophthalmology, vol. 111, no. 6, pp. 795-798, 
June 1993.
19. Mader, T. H., J. V. Aragones, A. C. Chandler, J. A. Hazlehurst, 
J. Heier, J. D. Kingham, and E. Stein, ``Ocular and Ocular Adnexal 
Injuries Treated by United States Military Ophthalmologists During 
Operations Desert Shield and Desert Storm,'' Ophthalmology, vol. 
100, no. 10, pp. 1462-1467, October 1993.
20. Morley, M. G., J. K. Nguyen, J. S. Heier, B. J. Shingleton, J. 
F. Pasternak, and K. S. Bower, ``Blast Eye Injuries: A Review for 
First Responders,'' Disaster Medicine and Public Health 
Preparedness, vol. 4, no. 2, pp. 154-160, June 2010.
21. Blozan, C. F. and S. A. Tucker, ``Premarket Notifications: The 
First 24,000,'' Medical Device & Diagnostic Industry, pp. 59-69, 
January 1986.
22. U.S. Department of Commerce, Bureau of Economic Analysis, 
National Income and Product Accounts Table 1.1.9 Implicit Price 
Deflators for Gross Domestic Product, http://www.bea.gov/iTable/iTable.cfm?ReqID=9&step=1, accessed January 17, 2013; National 
Income and Product Accounts Table 1.1.4 Price Indexes for Gross 
Domestic Product, http://www.bea.gov/iTable/iTable.cfm?ReqID=9&step=1, accessed January 17, 2013.
23. Geiger, D. R., ``FY 2003 and 2004 Unit Costs for the Process of 
Medical Device Review,'' September 2005, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109216.pdf.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    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 part 886 be 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 886.5700 is added to subpart F to read as follows:

Sec.  886.5700  Eyelid weight.

    (a) Identification. An eyelid weight is a prescription device made 
of gold, tantalum, platinum, iridium, or surgical grade stainless steel 
that is rectangular in shape and contoured to the shape of the eye. The 
device is intended for the gravity assisted treatment of lagophthalmos 
(incomplete eyelid closure).
    (1) The external eyelid weight is adhered to the outer skin of the 
upper eyelid.
    (2) The implantable eyelid weight is implanted into the upper 
eyelid.
    (b) Classification. (1) Class II (special controls) for the 
external eyelid weight. The external eyelid weight is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  886.9. The special controls 
for the external eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device;
    (ii) Nonclinical testing evaluating the compatibility of the device 
in a magnetic resonance (MR) environment;
    (iii) Labeling to include all information required for the safe and 
effective use of the device as outlined in Sec.  801.109(c) of this 
chapter, including specific instructions regarding the proper 
placement, sizing, and removal of the device; and
    (2) Class II (special controls) for the implantable eyelid weight. 
The special controls for the implantable eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device;
    (ii) Testing demonstrating the sterility and shelf life of the 
device;
    (iii) Nonclinical testing evaluating the compatibility of the 
device in an MR environment.
    (iv) Patient labeling to convey information regarding the safety 
and compatibility of the device in an MR environment, the conditions 
under which a patient with the device can be safely scanned, and a 
mechanism for a healthcare provider to obtain detailed information 
about MR safety and compatibility if needed.

    Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02862 Filed 2-7-13; 8:45 am]
BILLING CODE 4160-01-P