[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68714-68715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27365]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
classifying the scleral plug into class II (special controls), and 
exempting the scleral plugs composed of surgical grade stainless steel 
(with or without coating in gold, silver, or titanium) from premarket 
notification (510(k)) and continuing 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: This final rule is effective on December 16, 2013.

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

    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), Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), Food and Drug 
Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), and 
Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. 
L. 112-144), 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) 
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, 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).
    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.

II. Regulatory History of the Device

    In the Federal Register of January 25, 2013 (78 FR 5327), FDA 
proposed to classify scleral plug devices used to provide temporary 
closure of a scleral incision during an ophthalmic surgical procedure 
into class II (special controls) and proposed special controls for 
these devices. FDA also proposed to exempt the devices from premarket 
notification requirements if the device is made from surgical grade 
stainless steel (with or without a gold, silver, or titanium coating). 
FDA invited interested persons to comment on the proposed regulation by 
April 25, 2013. FDA received no comments on the proposed rule.

III. Summary of Final Rule

    In accordance with 21 CFR 860.84(g)(2), FDA is classifying scleral 
plugs into class II (special controls). FDA is codifying the 
classification of scleral plugs by adding Sec.  886.4155. The Agency is 
also exempting these devices from premarket notification requirements 
when they are made from surgical grade stainless steel (with or without 
a gold, silver, or titanium coating). The Agency has also identified 
special controls for scleral plug devices. Following the effective date 
of this final classification rule, manufacturers will

[[Page 68715]]

need to address the issues covered by these special controls.

IV. Analysis of Comments and FDA's Response

    FDA received no comments on the proposed rule. Therefore, under 
section 513 of the FD&C Act, FDA is adopting the proposed 
classification and FDA's finding. FDA is also adopting the assessment 
of the risks to public health stated in the proposed rule published on 
January 25, 2013. FDA is issuing this final rule which classifies the 
generic type of device, scleral plugs, into class II (special 
controls). In addition, FDA, on its own initiative, is exempting 
scleral plugs made from surgical grade stainless steel (with or without 
a gold, silver, or titanium coating) from premarket notification 
requirements.

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 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 the final regulation classifies a previously 
unclassified preamendment device type, there are only five registered 
establishments listed in the Establishment Registration and Device 
Listing database, and the regulation designating the classification of 
scleral plugs as class II is consistent with the historical regulatory 
oversight given to this device type, 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 $141 million, using the most current (2012) 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.

VII. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to 
previously 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 
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; the collections of 
information in part 807, subparts B and C, have been approved under OMB 
control number 0910-0387.

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, 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. 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 as follows:
    (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: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27365 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P