[Federal Register: June 12, 2007 (Volume 72, Number 112)]
[Rules and Regulations]
[Page 32170-32172]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn07-5]
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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