Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug, 68714-68715 [2013-27365]

Download as PDF 68714 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations requests for a hearing. We received no objections or requests for a hearing on the final rule. Therefore, we find that the effective date of the final rule that published in the Federal Register of August 13, 2013, should be confirmed. 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: List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379 e) and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Office of Food Additive Safety, we are giving notice that no objections or requests for a hearing were filed in response to the August 13, 2013, final rule. Accordingly, the amendments issued thereby became effective September 13, 2013. 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 Dated: November 8, 2013. Susan M. Bernard, Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition. [FR Doc. 2013–27381 Filed 11–14–13; 8:45 am] BILLING CODE 4160–01–P 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. 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 emcdonald on DSK67QTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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 § 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 E:\FR\FM\15NOR1.SGM 15NOR1 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations 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. 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. V. Environmental Impact VII. Paperwork Reduction Act of 1995 need to address the issues covered by these special controls. IV. Analysis of Comments and FDA’s Response 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. emcdonald on DSK67QTVN1PROD with RULES 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 VerDate Mar<15>2010 19:51 Nov 14, 2013 Jkt 232001 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 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. 2. In subpart E, add § 886.4155 to read as follows: ■ § 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 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 68715 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 § 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 E:\FR\FM\15NOR1.SGM 15NOR1

Agencies

[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.

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

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