[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Pages 5327-5330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01447]



[[Page 5327]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2012-N-1238]


Medical Devices; Ophthalmic Devices; Classification of the 
Scleral Plug

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to classify the scleral plug into class II (special controls), and 
proposing to exempt the scleral plugs composed of surgical grade 
stainless steel (with or without coating in gold, silver, or titanium) 
from premarket notification (510(k)) and to continue to require 
premarket notification (510(k)) for all other scleral plugs in order to 
provide a reasonable assurance of safety and effectiveness of the 
device. The scleral plug is a prescription device used to provide 
temporary closure of a scleral incision during an ophthalmic surgical 
procedure.

DATES: Submit either electronic or written comments by April 25, 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-2012-
N-1238, 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-2012-N-1238 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 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), the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (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 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 1976 amendments), as ``preamendments devices.'' FDA classifies 
these devices after the Agency takes the following steps: (1) Receives 
a recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes a 
final regulation classifying the device. FDA has classified most 
preamendments devices under these procedures.
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976, as ``postamendments devices.'' These devices are 
classified automatically by statute (section 513(f) of the FD&C Act (21 
U.S.C. 360c(f)) into class III without any FDA rulemaking process. 
These devices remain in class III and require premarket approval, 
unless and until: (1) FDA reclassifies the device into class I or II; 
(2) FDA issues an order classifying the device into class I or II in 
accordance with section 513(f)(2) of the FD&C Act, as amended by FDAMA; 
or (3) FDA issues an order finding the device to be substantially 
equivalent, under 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 and part 807 of the regulations (21 CFR 
Part 807).
    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 (PMA) until FDA issues 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 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 scleral plugs if 
the material is a surgical grade stainless steel with or without a 
gold, silver, or titanium coating.

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) (21 U.S.C. 360c(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 scleral plug 
was not identified in this initial effort. FDA has regulated scleral 
plugs as devices requiring premarket notification (510(k)). Scleral 
plugs currently on the market have been determined to be substantially 
equivalent to devices that were in commercial distribution prior to May 
28, 1976. Currently, FDA regulates scleral plugs as devices requiring 
premarket notification (510(k)). There have been ten 510(k) submissions 
received and cleared under product code LXP (scleral plugs).
    Consistent with the FD&C Act and the regulations, FDA consulted 
with the Ophthalmic Devices Panel (the Panel), an FDA advisory 
committee, regarding

[[Page 5328]]

the classification of this device type on January 22, 1996 (Ref. 1). At 
the panel meeting, the Panel recommended scleral plugs as 
classification as class I, 510(k) exempt. Two 510(k) submissions have 
been cleared since the panel meeting.

II. Recommendation of the Panel

    During a public meeting which was held on January 22, 1996, the 
Panel made recommendations regarding the classification and regulatory 
controls for the scleral plug. FDA is proposing the following 
identification based on the Panel's recommendations and the Agency's 
review:

A. Identification

    A scleral plug is a prescription device intended to provide 
temporary closure of a scleral incision during an ophthalmic surgical 
procedure. These plugs prevent intraocular fluid and pressure loss when 
instruments are withdrawn from the eye. Scleral plugs include a head 
portion remaining above the sclera, which can be gripped for insertion 
and removal, and a shaft that fits inside the scleral incision. Scleral 
plugs are removed before completing the surgery. Therefore, they are 
generally only used in operating rooms. These devices are often made of 
surgical grade stainless steel and can be coated in gold, silver, or 
titanium.
    Scleral plugs have a long and established history of clinical use. 
They are routinely used in many ophthalmic surgeries (specifically, 
vitreoretinal surgeries). One common type of vitreoretinal surgery is 
vitrectomy. Vitrectomy is estimated to be the third most frequently 
performed ophthalmic surgical operation, after cataract and excimer 
laser refractive surgery (Ref. 2). Approximately 225,000 vitrectomies 
are done in the United States each year (Ref. 2).

B. Recommended Classification of the Panel

    Although the Panel was informed that scleral plugs have 
historically been treated as class II devices, the Panel recommended 
that a scleral plug made of a material previously used in legally 
marketed devices be classified into class I (general controls) and be 
exempt from premarket notification because the biocompatibility and 
ability to be sterilized have already been established. The Panel's 
rationale for suggesting that the scleral plug be classified into class 
I was because general controls would provide reasonable assurance of 
the safety and effectiveness of the device type if it is made from a 
material established to be readily sterilized and biocompatible. During 
the panel discussion, a distinction was made that scleral plugs 
consisting of other materials (i.e., materials that are not already 
included in legally marketed medical devices to the date of the 
classification regulation) should be classified into class II and 
require biocompatibility testing as a special control.
    As a result of the distinction between materials used for this 
device, the Panel recommended that, unless new materials are proposed, 
the device should be exempt from premarket notification.

C. Summary of Reasons for Recommendation

    The Panel considered 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 over many years of 
clinical use. The Panel recommended that the scleral plug be classified 
into class I because it concluded that general controls would provide 
reasonable assurance of the safety and effectiveness of the device type 
if it was made from a material established to be readily sterilized and 
biocompatible. The Panel also recommended that scleral plugs be exempt 
from premarket notification requirements if the proposed device does 
not introduce new materials (i.e., materials that are not established 
to be safe for this type of application).
    However, FDA believes that a class II classification is appropriate 
and consistent with the intent of the Panel to establish requirements 
(such as biocompatibility and sterility) for these devices. Although 
the Panel identified potential risks and the measures that could be 
taken to mitigate these risks, the Panel's recommendation of class I 
would not permit FDA to establish as special controls the mitigation 
measures discussed (biocompatibility, sterility). Therefore, while FDA 
is not adopting the Panel's recommendation of classification into class 
I, the Agency agrees with the concerns and mitigation measures 
discussed by the Panel that would support a classification under class 
II.

D. Risks to Health

    Based on the Panel's discussion and recommendations and FDA's 
experience with the device, the risks to health associated with the 
scleral plugs made from surgical grade stainless steel with or without 
gold, silver, or titanium coating and the proposed measures to mitigate 
these risks are identified in table 1 of this document.

 Table 1--Health Risks and Mitigation Measures for the Scleral Plug Made
                   From Surgical Grade Stainless Steel
          [With or without a gold, silver, or titanium coating]
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility Testing.
Adverse Tissue Reaction...................  Biocompatibility Testing.
Loss, breakage, or migration of the plug..  Labeling.
------------------------------------------------------------------------

    For scleral plugs that are made of surgical grade stainless steel 
(with or without a gold, silver, or titanium coating) 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) Performance 
data must demonstrate the sterility and shelf life of the device; (2) 
the device must be demonstrated to be biocompatible; and (3) labeling 
must include all information required for the safe and effective use of 
the device, including specific instructions regarding the proper 
incision size, placement, and removal of the device.
    Because of the varying properties of other materials and the 
potential impact on safety and effectiveness, FDA has identified 
additional special controls for devices made of materials other than 
surgical grade stainless steel. Based on the Panel's discussion and 
recommendations and FDA's experience with the device, the risks to 
health associated with the scleral plugs made from materials other than 
surgical grade stainless steel and the proposed measures to mitigate 
these risks are identified in table 2 of this document.

  Table 2--Health Risks and Mitigation Measures for Scleral Plugs Made
        From Materials Other than Surgical Grade Stainless Steel
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Infection.................................  Sterility Testing.
                                            Shelf-life Testing.
Adverse Tissue Reaction...................  Biocompatibility testing.
                                            Material characterization.
                                            Performance testing to
                                             determine the level of
                                             extractables.

[[Page 5329]]

 
Loss, breakage, or migration of the plug..  Material characterization.
                                            Performance testing for
                                             Mechanical Properties.
                                            Labeling.
------------------------------------------------------------------------

    The Agency believes that the following special controls, in 
addition to general controls, will provide reasonable assurance of 
safety and effectiveness for scleral plugs that are composed of a 
material other than surgical grade stainless steel, as outlined in 
table 2: (1) Performance data must demonstrate the sterility and shelf 
life of the device; (2) the device must be demonstrated to be 
biocompatible; (3) characterization of the device materials must be 
performed; (4) performance data must demonstrate acceptable mechanical 
properties under simulated clinical use conditions including insertion 
and removal of the device; (5) performance data must demonstrate 
adequately low levels of the extractables or residues from 
manufacturing (or processing) of the device; and (6) labeling must 
include all information required for the safe and effective use of the 
device, including specific instructions regarding the proper incision 
size, placement, and removal of the device. In addition, the scleral 
plug is a prescription device and must be used in accordance with 21 
CFR 801.109.

III. Proposed Classification and FDA's Finding

    Adverse events involving scleral plugs are rare, as evidenced by 
the fact that FDA identified only a single adverse event in our 
reporting systems and two adverse events in the published literature 
(Refs. 3 and 4). The one adverse event reported to FDA resulted in no 
persistent adverse effects to the patient and, according to the report, 
this specific type of non-metallic scleral plug was discontinued and 
replaced with surgical grade stainless steel scleral plugs.
    FDA believes that a class II classification is consistent with the 
intent of the Panel to establish requirements (such as biocompatibility 
and sterility) for these devices. The identified special controls 
mitigate the known risks of the device that were identified by the 
Panel. However, the FDA does not agree with the Panel that all 
materials included in legally marketed scleral devices can be exempted 
from 510(k) due to the potential for safety concerns in some materials 
that will require specific material information and performance data to 
provide a reasonable assurance of safety and effectiveness. FDA 
believes this type of information should be reviewed by FDA prior to a 
device being marketed in the United States.
    FDA proposes the scleral plug be classified into class II. The 
special controls, in addition to general controls, will provide 
reasonable assurance of the safety and effectiveness of the device. FDA 
also agrees, in part, with the Panel's recommendation that premarket 
notification is not necessary to assure the safety and effectiveness of 
scleral plugs if new materials are not introduced and, therefore, the 
Agency is giving notice of intent to exempt the scleral plug device 
from premarket notification requirements if the device is made from 
surgical grade stainless steel (with or without a gold, silver, or 
titanium coating).

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

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and 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 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 the proposed regulation will classify a 
previously unclassified pre-Amendment device type, there are only five 
registered establishments listed in the Establishment Registration and 
Device Listing database, and the proposed regulation designating the 
classification of scleral plugs as class II is consistent with the 
historical regulatory oversight given to this device type, the Agency 
proposes to certify 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 $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.
    The proposed rule would impact current manufacturers if they were 
to make changes to their existing products and any manufacture wanting 
to market a new scleral plug. If the new or changed product is made of 
surgical grade stainless steel with or without gold, silver, or 
titanium coating, manufacturers could begin marketing after they 
complied with the proposed special controls. They would not need to 
submit an application to the Agency for preapproval. There would be no 
change from current requirements for new products made of alternative 
materials; they would need premarket notification before marketing.

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

[[Page 5330]]

number 0910-0485; the collections of information in 21 CFR part 807 
have been approved under OMB control number 0910-0387.

VIII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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 the Web site addresses of the following references, but FDA is 
not responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. Transcript from the Food and Drug Administration Ophthalmic 
Devices Panel Meeting, January 22, 1996.
    2. Chang, Stanley, ``LXII Edward Jackson Lecture: Open Angle 
Glaucoma After Vitrectomy,'' American Journal of Ophthalmology, vol. 
141(6): pp. 1033-1043, June 2006, available at http://www.sciencedirect.com/science/article/pii/S0002939406002546.
    3. Stewart, M. W., ``Intraoperative Radiographic Detection of a 
`Lost' Scleral Plug,'' Retina, vol. 25(4): pp. 526-527, June 2005.
    4. Bovino, J. A. and D. F. Marcus, ``Intraocular Foreign-Body 
Hazard During Vitrectomy,'' American Journal of Ophthalmology, vol. 
93 (3): p. 366, March 1982.

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, FDA proposes 
to amend part 886 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. In subpart E, add Sec.  886.4155 to read as follows:


Sec.  886.4155  Scleral plug.

    (a) Identification. A scleral plug is a prescription device 
intended to provide temporary closure of a scleral incision during an 
ophthalmic surgical procedure. These plugs prevent intraocular fluid 
and pressure loss when instruments are withdrawn from the eye. Scleral 
plugs include a head portion remaining above the sclera, which can be 
gripped for insertion and removal, and a shaft that fits inside the 
scleral incision. Scleral plugs are removed before completing the 
surgery.
    (b) Classification. Class II (special controls). The special 
controls for the scleral plug are:
    (1) The device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec.  886.9 if the material is a surgical grade stainless steel with or 
without a gold, silver, or titanium coating. The special controls for 
the surgical grade stainless steel scleral plug (with or without a 
gold, silver, or titanium coating) are:
    (i) The device must be demonstrated to be sterile during the 
labeled shelf life;
    (ii) The device must be demonstrated to be biocompatible; and
    (iii) Labeling must include all information required for the safe 
and effective use of the device, including specific instructions 
regarding the proper sizing, placement, and removal of the device.
    (2) The device is not exempt from premarket notification procedures 
if it is composed of a material other than surgical grade stainless 
steel (with or without a gold, silver, or titanium coating). The 
special controls for scleral plugs made of other materials are:
    (i) The device must be demonstrated to be sterile during the 
labeled shelf life;
    (ii) The device must be demonstrated to be biocompatible;
    (iii) Characterization of the device materials must be performed;
    (iv) Performance data must demonstrate acceptable mechanical 
properties under simulated clinical use conditions including insertion 
and removal of the device;
    (v) Performance data must demonstrate adequately low levels of the 
extractables or residues from manufacturing (or processing) of the 
device; and
    (vi) Labeling must include all information required for the safe 
and effective use of the device, including specific instructions 
regarding the proper sizing, placement, and removal of the device.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01447 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P