[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
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Recommended mitigation
Identified risk measures
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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.
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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