[Federal Register: April 30, 2002 (Volume 67, Number 83)]
[Rules and Regulations]
[Page 21171-21173]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap02-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 99P-1864]
Orthopedic Devices: Reclassification of the Hip Joint Metal/
Polymer Constrained Cemented or Uncemented Prosthesis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
hip joint metal/polymer constrained cemented or uncemented prosthesis
intended to replace a hip joint from class III (premarket approval) to
class II (special controls). FDA is also
[[Page 21172]]
identifying the guidance document entitled ``Class II Special Controls
Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or
Uncemented Prosthesis'' as the special control that the agency believes
will reasonably ensure the safety and effectiveness of the device. This
reclassification is being undertaken based on new information regarding
the device contained in a reclassification petition submitted by the
Orthopedic Surgical Manufacturers Association (OSMA), under the Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Medical
Device Amendments of 1976 (the 1976 Amendments), the Safe Medical
Devices Act of 1990 (SMDA), and the Food and Drug Administration
Moderization Act of 1997 (FDAMA). FDA is also revising the device
identification to accurately describe the device.
DATES: This regulation is effective May 30, 2002.
FOR FURTHER INFORMATION CONTACT: John S. Goode, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 6, 2001 (66 FR 46563), FDA
published a proposed rule to reclassify the hip joint metal/polymer
constrained cemented or uncemented prosthesis from class III to class
II based on new information respecting the device. FDA identified the
guidance document entitled ``Class II Special Controls Guidance: Hip
Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis'' as
the special control capable of providing reasonable assurance of safety
and effectiveness for the device.
Interested persons were given until December 5, 2001, to comment on
the proposed rule. FDA received three comments. Two comments commended
FDA's proposal to reclassify these devices and agreed that the guidance
proposed as the special control was adequate to provide reasonable
assurance of the safety and effectiveness of the device.
One comment stated that FDA's proposed special control was
inadequate to protect against certain types of device failure,
specifically shell-bone interface failure that may occur after
implantation of this highly constrained device. The comment stated that
this risk to health could only be addressed through a clinical testing
requirement in a premarket approval application. The comment stated
that the proposed rule was legally and procedurally flawed because FDA
failed to address this specific risk to health in the proposed rule.
FDA disagrees with the comment. FDA agrees that shell-bone
interface failure may occur after implantation of the device. FDA notes
that the Orthopedic and Rehabilitation Devices Panel (the Panel)
discussed this specific risk to health at the Panel meeting held on
November 4, 1999, that was cited in the September 6, 2001, proposed
rule to reclassify the device. Their recommendation to reclassify the
device from class III into class II was made in full awareness of this
risk to health because the Panel believed that this risk to health
could be controlled through implementation of special controls.
Although clinical trials were discussed at the meeting, the Panel did
not recommend that clinical trials be a special control to reasonably
assure the safety and effectiveness of this device. The agency
concurred with the Panel's recommendation. The ``Risks to Health''
section of the proposed rule included a discussion of possible revision
and of pain and/or loss of function due to a variety of causes,
including device failure. The agency believes that discussion of device
failure, as well as discussion of device failure in the draft guidance,
logically included device failures that were the result of problems
with the shell-bone interface. Although FDA did not specifically state
that the first bulleted precaution statement in the draft guidance
document was intended to address the risk of this specific device
failure, the agency believes that the scope of the precaution statement
in the draft guidance document did cover this risk. In order to provide
additional clarity, FDA has revised this precaution statement in the
final guidance document. Because the agency believes its proposed rule
and draft guidance raised the concerns associated with this risk and
because the final guidance includes further clarification, FDA does not
agree that the proposed rule was legally or procedurally flawed.
II. FDA's Conclusion
Based on a review of the available information referenced in the
preamble to the proposed rule and placed on file in FDA's Dockets
Management Branch, FDA concludes that the special controls, in
conjunction with general controls, provide reasonable assurance of the
safety and effectiveness of this device. The agency is also revising
the device identification to accurately describe the currently marketed
device. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance document.
III. Environmental Impact
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.
IV. 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. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness
Enforcement Act of 1996 (Public Law 104-121)), 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 consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review 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 will
relieve all manufacturers of these devices of the cost of complying
with the premarket approval requirements in section 515 of the act (21
U.S.C. 360e). Moreover, compliance with special controls for these
devices will not impose significant new costs on affected manufacturers
because most of these devices already comply with the special controls.
Because reclassification will reduce regulatory costs with respect to
these devices, it will impose no significant economic impact on any
small entities, and it may permit small potential competitors to enter
the marketplace by lowering their costs. The agency therefore certifies
that this final rule will not have a significant economic impact on a
substantial number of small entities. In addition, this final rule will
not impose costs of
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$100 million or more on either the private sector or State, local, or
tribal governments in the aggregate, and therefore a summary statement
or analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
V. 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 Executive order and, consequently, a
federalism summary impact statement is not required.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final rule does not contain information
collection provisions that are subject to review by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
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 888.3310 is revised to read as follows:
Sec. 888.3310 Hip joint metal/polymer constrained cemented or
uncemented prosthesis.
(a) Identification. A hip joint metal/polymer constrained cemented
or uncemented prosthesis is a device intended to be implanted to
replace a hip joint. The device prevents dislocation in more than one
anatomic plane and has components that are linked together. This
generic type of device includes prostheses that have a femoral
component made of alloys, such as cobalt-chromium-molybdenum, and an
acetabular component made of ultra-high-molecular-weight polyethylene
with or without a metal shell, made of alloys, such as cobalt-chromium-
molybdenum and titanium alloys. This generic type of device is intended
for use with or without bone cement (Sec. 888.3027).
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance: Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis.''
Dated: April 15, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-10509 Filed 4-29-02; 8:45 am]
BILLING CODE 4160-01-S