[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Proposed Rules]
[Pages 78239-78242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2008-N-0604]


General and Plastic Surgery Devices: Proposed Classification for 
the Tissue Expander

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify into class II (special controls) the tissue expander, as a 
device intended for temporary (less than 6 months) subdermal 
implantation to stretch the skin for surgical applications, 
specifically to develop surgical flaps and additional tissue coverage. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of the draft guidance that FDA intends will serve as the 
special control if FDA classifies this device type into class II.

DATES:  Submit written or electronic comments by March 23, 2009. See 
section IV of this document for the proposed effective date of a final 
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0604, 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 ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number 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: Nada Hanafi, Center for Devices and 
Radiological Health (HFZ-4), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8848.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 
94-295), the Safe Medical Devices Act of 1990 (Public Law 101-629), and 
the Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 105-
115), the Food and Drug Administration Amendments Act of 2007 (Public 
Law 110-85), among other amendments, established a comprehensive system 
for the regulation of medical devices intended for human use. Section 
513 of the 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 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 has taken the following steps:

[[Page 78240]]

    (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 type; and
    (3) Publishes a final regulation classifying the device type.
    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 device types 
are classified automatically by statute (section 513(f) of the act) 
into class III without any FDA rulemaking process. Those device types 
remain in class III and require premarket approval, unless and until:
    (1) FDA reclassifies the device type into class I or II;
    (2) FDA issues an order classifying the device type into class I or 
II in accordance with new section 513(f)(2) of the act, as amended by 
FDAMA; or
    (3) FDA issues an order finding the device to be substantially 
equivalent, under section 513(i) of the act, to a predicate device that 
does not require premarket approval.
    The agency determines whether new devices are substantially 
equivalent to previously offered devices by means of premarket 
notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) 
and 21 CFR part 807 of the regulations.
    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 act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    The tissue expander is a preamendment device type that was not 
classified in the final rule published in the Federal Register of June 
24, 1988, classifying other General and Plastic Surgery Devices (53 FR 
23856). Consistent with the act and the regulations, FDA consulted with 
the Panel, an FDA advisory committee, regarding the classification of 
this device type.

II. Recommendation of the Panel

    At a public meeting held on August 25 and 26, 2005, the Panel 
unanimously recommended that the tissue expander be classified into 
class II (Ref. 1). The Panel believed that class II, special controls, 
in addition to general controls, would reasonably assure the safety and 
effectiveness of this device type. The Panel also recommended that the 
special control for the device type be a guidance document.

A. Identification

    FDA is proposing the following identification based on the Panel's 
recommendation and the available information: A tissue expander is a 
device intended for temporary (less than 6 months) subdermal 
implantation to stretch the skin for surgical applications, 
specifically to develop surgical flaps and additional tissue coverage. 
It is made of an inflatable silicone elastomer shell filled with Normal 
Physiological Saline (injection grade).

B. Recommended Classification of the Panel

    The Panel unanimously recommended that the tissue expander be 
classified into class II. The Panel believed that class II with the 
special controls (a guidance document and labeling) would provide 
reasonable assurance of the safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of the draft guidance that will serve as the special 
control for this device type.

C. Summary of Reasons for Recommendation

    After reviewing the information provided by FDA, and after 
consideration of the open discussions during the Panel meeting and the 
Panel members' personal knowledge of and clinical experience with the 
device system, the Panel provided the following reasons in support of 
its recommendation to classify the generic device type, tissue expander 
intended for temporary (less than 6 months) subdermal implantation to 
develop surgical flaps and additional coverage for surgical 
applications, into class II. The Panel believed the tissue expander 
should be classified into class II because special controls, in 
addition to general controls, would provide reasonable assurance of the 
safety and effectiveness of the device and there is sufficient 
information to establish special controls to provide such assurance.

D. Summary of the Data Upon Which the Recommendation is Based

     In addition to the potential risks to health associated with 
implantation of the tissue expander described in section II.E of this 
document, ``Risks to Health,'' there is reasonable knowledge of the 
benefits of the device type. Specifically, the tissue expander develops 
tissue flaps and coverage needed for surgical applications, such as 
breast reconstruction following mastectomy, treatment of underdeveloped 
breasts, scar revision, and treatment of soft tissue deformities or 
injuries.

E. Risks to Health

    After considering the Panel's comments and recommendation, the 
published literature, and medical device reports, FDA has evaluated the 
risks to health associated with use of the tissue expander. FDA 
believes the following are risks to health associated with use of the 
device type:
    Skin trauma, including necrosis, thinning and slough;
    Device failure, including rupture and injection site/port failure;
    Infection--Infection is a risk to health associated with all 
surgical procedures and implanted devices. Incompatible or impure 
material composition may irritate the surrounding tissue which could 
increase the risk of infection. Use of a device that is not pyrogen 
free may elicit a fever.
    Adverse tissue reaction--Adverse tissue reaction is a risk to 
health common to all implanted devices. The implantation of the tissue 
expander will elicit a mild inflammatory reaction typical of a normal 
foreign body response. Incompatible material or impurities in the 
materials may increase the severity of a local tissue reaction or cause 
a systemic tissue reaction.
    Pain--Pain is a risk to health associated with all surgical 
procedures and implanted devices.

F. Special Controls

    In addition to general controls, FDA believes that the draft 
guidance document entitled ``Class II Special Controls Guidance: Tissue 
Expander'' (the draft class II special controls guidance document) is a 
special control adequate to address the risks to health associated with 
the use of the device type described in section II.E of this document. 
FDA believes that the draft class II special controls guidance document 
addresses the Panel's concerns and provides reasonable assurance of the 
safety and effectiveness of the device type. Elsewhere in this issue of 
the Federal Register, FDA is publishing a notice of availability of the 
draft class II special controls guidance document that the agency would 
use as the special control for this device type.
    The draft class II special controls guidance document sets forth 
the information FDA recommends submitters include in premarket 
notification submissions (510(k)s) for a tissue expander. FDA has 
identified the risks to health associated with the use

[[Page 78241]]

of the device type in the first column of table 1 of this document. The 
recommended mitigation measures identified in the draft class II 
special controls guidance document is in the second column of table 1 
of this document. FDA believes that addressing these risks to health in 
a 510(k) in the manner identified in the draft class II special 
controls guidance document, or in an acceptable alternative manner, is 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device type.

            Table 1.--Risks to Health and Mitigation Measures
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           Identified Risk              Recommended Mitigation  Measures
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Skin trauma (e.g., necrosis,           Labeling
 thinning, sloughing).
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Device failure (e.g., rupture,         Preclinical testing
 injection site/port failure).         Labeling
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Infection............................  Sterility
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Adverse tissue reaction..............  Biocompatibility
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Pain.................................  Labeling
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III. Proposed Classification

    FDA concurs with the Panel's recommendation that a tissue expander 
should be classified into class II because special controls, in 
addition to general controls, would provide reasonable assurance of the 
safety and effectiveness of the device, and there is sufficient 
information to establish special controls to provide such assurance.

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 proposed 
classification 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 the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 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 proposed 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. Classification of this device type into class II 
will have a negligible impact on manufacturers because manufacturers of 
the device type currently must provide premarket notification before 
marketing the device and because FDA believes that manufacturers are 
already substantially in compliance with the recommendations in the 
draft guidance document. Because classification into class II will not 
increase regulatory costs with respect 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 $130 million, using the most current (2007) 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.

VII. Federalism

    FDA has analyzed this proposed 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 preempts certain State requirements ``different or in 
addition to'' certain federal requirements applicable to devices (21 
U.S.C. 360k; Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. 
Medtronic, 128 S.Ct. 999 (2008)). In this proposed rulemaking, FDA has 
tentatively determined that general controls by themselves are 
insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, and that there is sufficient information 
to establish special controls to provide such assurance. FDA therefore 
proposes to establish special controls to address the issues of safety 
or effectiveness identified in the special controls draft guidance 
document. If this proposed rule is made final, these special controls 
would create ``requirements'' for specific medical devices under 21 
U.S.C. 360k, even though product sponsors would have some flexibility 
in how they meet those requirements (Papike v. Tambrands, Inc., 107 
F.3d 737, 740-42 (9th Cir. 1997)).
    In addition, if this rule becomes final, as with any Federal 
requirement, if a State law requirement makes compliance with both 
Federal law and State law impossible, or would frustrate Federal 
objectives, the State requirement would be preempted. (See Geier v. 
American Honda Co., 529 U.S. 861 (2000); English v. General Electric 
Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373 
U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).)

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520) is not required. This proposed rule designates a 
guidance document as a special control.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability of the draft guidance document entitled 
``Class II Special Controls Guidance Document: Tissue Expander,'' which 
contains an analysis of the paperwork burden for the draft guidance.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy.

[[Page 78242]]

Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

X. References

    The following reference has 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.
    1. General and Plastic Surgery Devices Panel, Transcript, August 
25 and 26, 2005, pp. 11 through 58 of the August 26, 2005, 
transcripts.

List of Subjects in 21 CFR Part 878

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend 21 CFR part 878 as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    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.
    2. Add Sec.  878.3600 to subpart D to read as follows:


Sec.  878.3600  Tissue expander.

    (a)  Identification. A tissue expander is a device intended for 
temporary (less than 6 months) subdermal implantation to stretch the 
skin for surgical applications, specifically to develop surgical flaps 
and additional tissue coverage. It is made of an inflatable silicone 
elastomer shell filled with Normal Physiological Saline (injection 
grade).
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Tissue Expander.'' See Sec.  
878.1(e) for availability information of guidance documents.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30439 Filed 12-19-08; 8:45 am]
BILLING CODE 4160-01-S