[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Rules and Regulations]
[Pages 21171-21173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10509]


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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

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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