[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Rules and Regulations]
[Pages 68972-68974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2010-N-0512]


Medical Devices; General and Plastic Surgery Devices; 
Classification of Tissue Adhesive With Adjunct Wound Closure Device 
Intended for Topical Approximation of Skin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
tissue adhesive with adjunct wound closure device intended for topical 
approximation into class II (special controls). The special control 
that will apply to the device is the guidance document entitled 
``Guidance for Industry and FDA Staff; Class II Special Controls 
Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device 
Intended for the Topical Approximation of Skin.'' The agency is 
classifying the device into class II (special controls) in order to 
provide reasonable assurance of safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a guidance document that will serve as the special 
control for this device type.

DATES: This final rule is effective December 10, 2010. The 
classification was effective April 30, 2010.

FOR FURTHER INFORMATION CONTACT: George J. Mattamal, Center for Devices 
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 
4617, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
6396.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    The Federal Food, Drug, and Cosmetic Act (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), and the Food and Drug Administration Modernization 
Act (Pub. L. 107-250) 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. 306c) established three categories (classes) of 
devices, depending on the regulatory controls needed to provide 
reasonable assurance of their safety and

[[Page 68973]]

effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976 (the date of enactment of the 1976 amendments), as 
postamendments devices. Postamendments 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: (1) FDA reclassifies the 
device into class I or II; (2) FDA issues an order classifying the 
device into class I or class II in accordance with section 513(f)(2) of 
the FD&C Act; or FDA issues an order finding the device to be 
substantially equivalent, under section 513(i), to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1). FDA will, 
within 60 days of receiving this request, classify the device by 
written order. This classification shall be the initial classification 
of the device. Within 30 days after the issuance of an order 
classifying the device, FDA must publish a notice in the Federal 
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on February 25, 2009, classifying the PRINEO Skin Closure System 
into class III, because it was not substantially equivalent to a device 
that was introduced or delivered for introduction into interstate 
commerce for commercial distribution before May 28, 1976, or a device 
which was subsequently reclassified into class I or class II. On March 
23, 2009, Closure Medical Corp. submitted a petition requesting 
classification of the tissue adhesive with adjunct wound closure device 
for topical approximation of skin under section 513(f)(2) of the FD&C 
Act. The manufacturer recommended that the device be classified into 
class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA determined that tissue 
adhesive with adjunct wound closure device intended for topical 
approximation of skin can be classified into class II with the 
establishment of special controls. FDA believes these special controls 
will provide reasonable assurance of the safety and effectiveness of 
the device.
    The device is assigned the generic name ``Tissue Adhesive with 
Adjunct Wound Closure Device Intended for Topical Approximation of 
Skin'' and it is identified as tissue adhesive with adjunct wound 
closure device intended for topical approximation of skin. FDA has 
identified the following risks to health associated specifically with 
this type of device and the recommended measures to mitigate these 
risks.
    A. Unintentional bonding of device due to misapplication of device, 
device leaking or running to unintended areas, etc.
    B. Wound dehiscence
    C. Adverse tissue reaction and chemical burns
    D. Infection
    E. Applicator malfunction
    F. Weak bonding leading to loss of approximation
    G. Delayed polymerization

            Table 1--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
                                             Recommended  mitigation
            Identified risk                          measures
------------------------------------------------------------------------
Unintentional bonding of device due to   Bench Testing, Labeling.
 misapplication of device, device
 leaking or running to unintended
 areas, etc.
Wound dehiscence.......................  Bench Testing, Shelf Life
                                          Testing, Animal Testing,
                                          Clinical Studies, Labeling.
Adverse tissue reaction and chemical     Biocompatibility Animal
 burns.                                   Testing, Clinical Studies.
Infection..............................  Bench Testing, Biocompatibility
                                          Animal Testing, Clinical
                                          Studies, Sterility.
Applicator malfunction.................  Bench Testing.
Weak bonding leading to loss of          Bench Testing, Animal Testing,
 approximation.                           Clinical Studies.
Delayed polymerization.................  Bench Testing, Animal Testing.
------------------------------------------------------------------------

    FDA believes that the special controls guidance document, in 
addition to general controls, addresses the risks to health identified 
in table 1 of this document and provides reasonable assurance of the 
safety and effectiveness of the device. Therefore, on April 30, 2010, 
FDA issued an order to the petitioner classifying the device into class 
II. FDA is codifying this device by adding Sec.  878.4011 to 21 CFR 
part 878.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for tissue adhesive 
with adjunct wound closure device intended for topical approximation of 
skin will need to address the issues covered in the special controls 
guidance. However, the firm need only show that its device meets the 
recommendations of the guidance or in some other way provides 
equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirement under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device and, 
therefore, the type of device is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification prior to marketing the

[[Page 68974]]

device, which contains information about the tissue adhesive with 
adjunct wound closure intended for topical approximation of skin that 
they intend to market.

II. What is the environmental impact of this rule?

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the analysis impact of this rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs 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 as defined by 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of this device from class 
III to class II will relieve manufacturers of the device of cost of 
complying with the premarket approval requirements of section 515 of 
the FD&C Act (21 U.S.C. 360e), and may permit small potential 
competitors to enter the marketplace by lowering their costs, the 
agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.''
    The current threshold after adjustment for inflation is $135 
million, using the most current (2009) Implicit Price Deflator for the 
Gross Domestic Product. FDA does not expect this final rule to result 
in any 1-year expenditure that would meet or exceed this amount.

IV. Does this final rule have Federalism Implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempt certain State requirements ``different from or in addition 
to'' certain Federal requirements applicable to devices. 21 U.S.C. 
360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, 
552 U.S. 312 (2008). The special controls established by this final 
rule create ``requirements'' to address each identified risk to health 
presented by these specific medical devices under 21 U.S.C. 360k, even 
though product sponsors have some flexibility in how they meet those 
requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th 
Cir. 1997).

V. How does this rule comply with the Paperwork Reduction Act of 1995?

    This final rule contains no new collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 is not required. Elsewhere in this 
issue of the Federal Register, FDA is issuing a notice announcing the 
availability of a guidance for the final rule. The guidance, ``Class II 
Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound 
Closure Device Intended for the Topical Approximation of Skin,'' 
references previously approved collections of information found in 
FDA's regulations.

VI. What references are on display?

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Closure Medical Corp., March 23, 2009.

List of Subjects in 21 CFR Part 878

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 3601, 371.

0
2. Section 878.4011 is added to subpart E to read as follows:


Sec.  878.4011  Tissue adhesive with adjunct wound closure device for 
topical approximation of skin.

    (a) Identification. A tissue adhesive with adjunct wound closure 
device intended for the topical approximation of skin is a device 
indicated for topical application only to hold closed easily 
approximated skin edges of wounds from surgical incisions, including 
punctures from minimally invasive surgery, and simple, thoroughly 
cleansed, trauma-induced lacerations. It may be used in conjunction 
with, but not in place of, deep dermal stitches. Additionally, the 
adjunct wound closure device component maintains temporary skin edge 
alignment along the length of wound during application of the liquid 
adhesive.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Guidance for Industry and FDA Staff; 
Class II Special Controls Guidance Document: Tissue Adhesive with 
Adjunct Wound Closure Device Intended for the Topical Approximation of 
Skin.'' See Sec.  878.1(e) for the availability of this guidance 
document.

    Dated: November 4, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28356 Filed 11-9-10; 8:45 am]
BILLING CODE 4160-01-P