[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Proposed Rules]
[Pages 6710-6713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1736]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 2006N-0019]
Orthopedic Devices; Reclassification of the Intervertebral Body
Fusion Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify intervertebral body fusion devices that contain bone
grafting material, from class III (premarket approval) into class II
(special controls), and retain those that contain any therapeutic
biologic (e.g., bone morphogenic protein) in class III. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of a draft guidance document that would serve as the special control if
FDA reclassifies this device. The agency is proposing this
reclassification based on the recommendation of the Orthopaedic and
Rehabilitation Devices Panel (the Panel).
DATES: Submit written or electronic comments by May 10, 2006. See
section X 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. 2006N-
0019, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the followings 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 or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
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.fda.gov/ohrms/dockets/default.htm,
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.fda.gov/ohrms/dockets/default.htm
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: Jodi N. Anderson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036, ext. 186.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), 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), the Food and Drug Administration Modernization
Act of 1997 (Public Law 105-115), and the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250), 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, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has done the following: (1) Received a
recommendation from a device classification panel (an FDA advisory
committee); (2) published the panel's
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recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or 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
predicate devices by means of premarket notification procedures in
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part
807) of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of 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.
Reclassification of classified postamendments devices is governed
by section 513(f ) of the act. This section provides that FDA may
initiate the reclassification of a device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device may petition the Secretary of Health and Human Services (the
Secretary) for the issuance of an order classifying the device in class
I or class II. FDA's regulations in 21 CFR 860.134 set forth the
procedures for the filing and review of a petition for reclassification
of such class III devices. In order to change the classification of the
device, it is necessary that the proposed new class have sufficient
regulatory controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use.
Under section 513(f)(3)(B)(i) of the act, the Secretary may, for
good cause shown, refer a proposed reclassification to a device
classification panel. The Panel shall make a recommendation to the
Secretary respecting approval or denial of the proposed
reclassification. Under section 513(f)(3)(B)(i), any such
recommendation must contain the following: (1) A summary of the reasons
for the recommendation, (2) a summary of the data upon which the
recommendation is based, and (3) an identification of the risks to
health (if any) presented by the device with respect to which the
proposed reclassification was initiated.
II. Regulatory History of the Device
The intervertebral body fusion device is a postamendments device
classified into class III under section 513(f)(1) of the act. It is
intended for intervertebral body fusion. The intervertebral body fusion
device cannot be placed in commercial distribution for implantation
unless it is reclassified under section 513(f)(3), or subject to an
approved PMA under section 515 of the act.
Based on information discussed at a December 11, 2003, Panel
meeting (see section IV of this document) regarding the intervertebral
body fusion device, the FDA believes potential risks associated with
the intervertebral body fusion device, except those that contain any
therapeutic biologic, can be addressed by special controls in the form
of a guidance document. Thus, FDA is proposing to reclassify
intervertebral body fusion devices that contain bone grafting material
from class III into class II. Consistent with the act and the
regulation, FDA referred the proposal to the Panel for its
recommendation on the requested changes in classification.
Intervertebral body fusion devices that include any therapeutic
biologic (e.g., bone morphogenic protein) will remain in class III. FDA
believes that there is insufficient information to determine that
general and special controls would provide a reasonable assurance of
their safety and effectiveness.
III. Device Description
The following device description is based on the Panel's
recommendation and the agency's review:
An intervertebral body fusion device is an implanted single or
multiple component spinal device made from a variety of materials,
including titanium and polymers. The device is inserted into the
intervertebral body space of the cervical or lumbosacral spine, and is
intended for intervertebral body fusion.
IV. Recommendation of the Panel
At a public meeting on December 11, 2003, the Panel recommended
unanimously that the intervertebral body fusion device, except those
that contain any therapeutic biologic, be reclassified from class III
into class II (Ref. 1). The Panel believed that class II with special
controls, in addition to the general controls, would provide reasonable
assurance of the safety and effectiveness of the device. The Panel also
recommended that the proposed special controls for the device be
mechanical, animal, and clinical testing, labeling, sterilization, and
biocompatibility as suggested by FDA staff.
V. Risks to Health
After considering the information in the Panel's recommendation, as
well as other information, including Medical Device Reports (MDRs), FDA
has evaluated the risks to health associated with use of the
intervertebral body fusion device that contains bone grafting material
and determined that the following risks to health are associated with
its use:
A. Infection
Infection of the soft tissue, bony tissue, and the disc space is a
potential risk to health associated with all surgical procedures and
implanted spinal devices. Material composition or impurities, wear
debris, operative time, and operative environment may compromise the
vascular supply to the area or affect the immune system, which could
increase the risk of infection. Improper sterilization or packaging may
also increase the risk of infection.
B. Adverse Tissue Reaction
Adverse tissue reaction is a potential risk to health associated
with all implanted devices. The implantation of the intervertebral body
fusion device will elicit a mild inflammatory reaction typical of a
normal foreign body response. Incompatible materials or impurities in
the materials and wear debris may increase the severity of a local
tissue reaction or cause a systemic tissue reaction. If the materials
used in the manufacture of intervertebral body fusion device are not
biocompatible, the patient could have an adverse tissue reaction.
C. Pain and Loss of Function
Pain and loss of function are risks to health associated with any
implanted spinal device. Some device-related complications that may
cause pain and loss of function include device fracture, deformation,
loosening, extrusion, or migration due to inappropriate patient or
device selection. The wear of materials, which may cause osteolysis
(dissolution of bone), and component disassembly, fracture, or failure
may also result in pain and loss of function.
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D. Soft Tissue Injury
Soft tissue injury is a risk to health associated with all spinal
surgery. This includes injury to major blood vessels, viscera, nerve
roots, spinal cord, and cauda equina.
E. Vertebral Endplate Injury
Vertebral endplate injury is a risk to health associated with the
insertion of an intervertebral body fusion device. Surgically inserting
a device with a different geometry and modulus of elasticity than bone
may lead to vertebral fracture, sinking of the device into the
vertebral endplate (subsidence), collapse of the local blood supply,
and collapse of the vertebral end plate.
F. Reoperation
Reoperation is a risk to health associated with any surgery. The
need for reoperation could result from a failed intervertebral body
device or component of the device, from nerve root decompression or
adjacent level disease, or from reasons related to any surgery, e.g.,
infection or bleeding.
G. Pseudarthrosis (i.e., non-union)
Pseudarthrosis (i.e., non-union) is a risk associated with all
spinal fusion surgeries. It signifies failure of the bony fusion mass
and results in persistent instability.
VI. Summary of the Reasons for the Reclassification
FDA believes that the intervertebral body fusion device that
contains bone grafting material should be reclassified into class II
because special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device. In
addition, there is sufficient information to establish special controls
to provide such assurance.
VII. Summary of the Data Upon Which the Reclassification is Based
As discussed previously in this document, FDA is proposing this
reclassification based on the Panel's recommendation. In addition FDA
has reviewed MDRs related to this device. After evaluating this
information, FDA believes that the potential risks to health associated
with use of the intervertebral body fusion device described in section
V of this document can be addressed by special controls. In addition,
there is reasonable knowledge of the benefits of the device, including
the provision of mechanical support, which aids in fusion procedures of
the anterior spinal column.
VIII. Special Controls
FDA believes that the draft guidance document entitled ``Class II
Special Controls Guidance Document: Intervertebral Body Fusion Device''
(the class II special controls guidance document), in addition to
providing general controls, can address the risks to health associated
with the use of the device and described in section V of this document.
FDA believes further that the class II special controls guidance
document, which incorporates voluntary consensus standards and labeling
recommendations, addresses the Panel's concerns regarding the content
of a special controls guidance document. Elsewhere in this issue of the
Federal Register, FDA is publishing a notice of availability of the
draft guidance document that the agency intends to use as the special
control for this device.
The class II special controls guidance document contains specific
recommendations with regard to device performance testing and other
information FDA believes should be included in premarket notification
submissions (510(k)s) for the intervertebral body fusion device that
contains bone grafting material. Sections of the draft special controls
guidance document address the following topics: Material
characterization, mechanical testing, animal testing, clinical testing,
sterility, biocompatibility, and labeling. FDA has identified the risks
to health associated with the use of the device in the first column of
table 1 of this document and the recommended mitigation measures
identified in the class II special controls guidance document in the
second column.
Table 1.
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Identified Risk Recommended Mitigation Measures
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Infection Sterility
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Adverse Tissue Reaction Biocompatibility
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Pain and Loss of Function Mechanical Testing
Animal Data
Clinical Data
Labeling
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Soft Tissue Injury Labeling
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Vertebral Endplate Injury Material Characterization
Mechanical Testing
Biocompatibility
Labeling
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Reoperation Labeling
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Psuedoarthrosis (i.e., non- Labeling
union)
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Following the effective date of a final rule based on this
proposal, any firm submitting a 510(k) premarket notification for an
intervertebral body fusion device 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.
IX. FDA's Findings
FDA believes the intervertebral body fusion device that contains
bone grafting material should be reclassified into class II because
special controls, in addition to general controls, can provide
reasonable assurance of the safety and effectiveness of the device. In
addition, there is sufficient information to establish special controls
to provide such assurance. FDA, therefore, is proposing to reclassify
the intervertebral body fusion device that contains bone grafting
material into class II and establish the class II special controls
guidance document as the special control for that device, and to retain
in class III those devices that contain any therapeutic biologic.
X. Effective Date
FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
XI. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
reclassification 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.
XII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, 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,
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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. Reclassification of this device from class III to
class II will relieve all manufacturers of the device of the costs of
complying with the premarket approval requirements in section 515 of
the act. Because reclassification will reduce regulatory costs with
respect to this device, the agency certifies that the proposed 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 $115 million, using the most current (2003) 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.
XIII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement has not been prepared.
XIV. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520) is not required.
FDA also tentatively concludes that the special controls guidance
document does not contain new information collection provisions that
are subject to review and clearance by OMB under the PRA. Elsewhere in
this issue of the Federal Register, FDA is publishing a notice
announcing the availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Intervertebral Body
Fusion Device;'' the notice contains an analysis of the paperwork
burden for the draft guidance.
XV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this proposal.
Submit a single copy of electronic comments or two paper copies of
mailed comments, except that individuals may submit one paper copy.
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.
XVI. 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. Orthopedic and Rehabilitation Devices Panel Meeting Transcript,
pp. 1-141, December 11, 2003.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 888 be amended as follows:
PART 888--ORTHOPEDIC DEVICES
1. The authority citation for 21 CFR part 888 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 888.3080 is added to subpart D to read as follows:
Sec. 888.3080 Intervertebral body fusion device.
(a) Identification. An intervertebral body fusion device is an
implanted single or multiple component spinal device made from a
variety of materials, including titanium and polymers. The device is
inserted into the intervertebral body space of the cervical or
lumbosacral spine, and is intended for intervertebral body fusion.
(b) Classification. (1) Class II (special controls) for
intervertebral body fusion devices that contain bone grafting material.
The special control is the FDA guidance document entitled ``Class II
Special Controls Guidance Document: Intervertebral Body Fusion
Device.'' See Sec. 888.1(e) for the availability of this guidance
document.
(2) Class III (premarket approval) for intervertebral body fusion
devices that include any therapeutic biologic (e.g., bone morphogenic
protein). Intervertebral body fusion devices that contain any
therapeutic biologic require premarket approval.
(c) Date premarket approval application (PMA) or notice of product
development protocol (PDP) is required. Devices described in paragraph
(b)(2) of this section shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
Dated: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-1736 Filed 2-8-06; 8:45 am]
BILLING CODE 4160-01-S