[Federal Register Volume 72, Number 112 (Tuesday, June 12, 2007)]
[Rules and Regulations]
[Pages 32170-32172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11240]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying 
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 guidance 
document that will serve as the special control for this device. This 
reclassification is based upon on the recommendation of the Orthopaedic 
and Rehabilitation Devices Panel (the Panel).

EFFECTIVE DATE: July 12, 2007.

FOR FURTHER INFORMATION CONTACT: Jodi N. Anderson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Boulevard, Rockville, MD 20850, 240-276-3680.

SUPPLEMENTARY INFORMATION:

I. Background

    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 (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 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 before 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 
previously offered 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 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.
    Section 513(e) of the act (21 U.S.C. 360c(e)) governs 
reclassification of classified preamendments devices. This section 
provides that FDA may, by rulemaking, reclassify a device (in a 
proceeding that parallels the initial classification proceeding) based 
upon ``new information.'' FDA can initiate a reclassification under 
section 513(e) of the act or an interested person may petition FDA to 
reclassify a preamendments device. The term ``new information,'' as 
used in section 513(e) of the act, includes information developed as a 
result of a reevaluation of the data before the agency when the device 
was originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland Rantos v. 
United States Department of Health, Education, and Welfare, 587 F.2d 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

[[Page 32171]]

    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data 
before the agency are past or new data, the ``new information'' to 
support reclassification under section 513(e) must be ``valid 
scientific evidence,'' as defined in section 513(a)(3) of the act and 
21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 
214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. 
Cir.), cert. denied, 474 U.S. 1062 (1985)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the valid scientific 
evidence upon which the agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the act (21 U.S.C. 360j(c).) Section 
520(h)(4) of the act, added by FDAMA, provides that FDA may use, for 
reclassification of a device, certain information in a PMA 6 years 
after the application has been approved. This includes information from 
clinical and preclinical tests or studies that demonstrate the safety 
or effectiveness of the device but does not include descriptions of 
methods of manufacture or product composition and other trade secrets.
    FDAMA added a new section 510(m) to the act. New section 510(m) of 
the act provides that a class II device may be exempted from the 
premarket notification requirements under section 510(k) of the act, if 
the agency determines that premarket notification is not necessary to 
assure the safety and effectiveness of the device. FDA believes that 
this device should not be exempt from premarket notification under 
section 510(m) of the act. FDA believes that it needs to review 
information in a premarket notification submission that addresses the 
risks identified in the guidance document in order to assure that a new 
device is at least as safe and effective as legally marketed devices of 
this type.

II. Regulatory History of the Device

    In the Federal Register of February 9, 2006 (71 FR 6710), FDA 
published a proposed rule to reclassify the 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. FDA received 12 comments on the proposed rule and draft 
guidance.
    In the same issue of the Federal Register of February 9, 2006 (71 
FR 6778), FDA announced the availability of the draft guidance document 
entitled ``Class II Special Controls Guidance Document: Class II 
Special Controls Guidance Document: Intervertebral Body Fusion Device'' 
that FDA intended to serve as the special control for this device type, 
if FDA reclassified this device type. Interested persons were invited 
to comment on the proposed rule and special controls draft guidance 
document by May 10, 2006.

III. Summary of Final Rule

    Therefore, under sections 513 and 520(l) of the act, FDA is 
adopting the summary of reasons for the panel's recommendation, the 
summary of data upon which the panel's recommendations are based (Ref. 
1), and the assessment of the risks to public health stated in the 
proposed rule published on February 9, 2006. Furthermore, FDA is 
issuing this final rule (21 CFR 888.3080), that reclassifies 
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.

IV. Analysis of Comments and FDA's Response

    FDA received six comments stating the comment's full support for 
the reclassification as proposed and offering no additional input. Two 
comments suggested adding thoracic use to the classification 
identification. FDA disagrees with this comment because there are no 
legally marketed intervertebral body fusion devices indicated for 
thoracic use, and thus there is no experience with thoracic use of the 
intervertebral body fusion device. Two comments suggested that FDA 
classify all intervertebral body fusion devices into class II 
regardless of the grafting material the devices contain and regardless 
of whether grafting materials composed of therapeutic biologics remain 
class III. FDA disagrees with this comment. The intervertebral body 
fusion device and the grafting material it contains do not act 
independently in the body, thus the mitigation measures described in 
the special controls guidance are insufficient to provide reasonable 
assurance of safety and effectiveness for an intervertebral body fusion 
device when it contains a therapeutic biologic grafting material. The 
two remaining comments pertained to scientific recommendations in the 
draft guidance. FDA's consideration of these two comments is discussed 
in the notice of the availability of the guidance, published elsewhere 
in this issue of the Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
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.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-602), 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 final rule is not a significant regulatory action under 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 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 an 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

[[Page 32172]]

or more (adjusted annually for inflation) in any one year.'' The 
current threshold after adjustment for inflation is $122 million, using 
the most current (2005) 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. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that 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 has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) is not required. Elsewhere in 
this issue of the Federal Register, FDA is publishing a notice of 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Intervertebral Body Fusion Devices.'' The 
notice contains the PRA analysis for the guidance.

IX. 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.

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

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for 21 CFR part 888 continues to read 
asfollows:

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

0
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: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11240 Filed 6-11-07; 8:45 am]
BILLING CODE 4160-01-S