[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Proposed Rules]
[Pages 46563-46567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 99P-1864]


Orthopedic and Rehabilitation Devices: Reclassification of the 
Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify 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). The agency is also 
proposing to revise the device identification. This reclassification is 
based upon new information regarding the device contained in a 
reclassification petition submitted by the Orthopedic Surgical 
Manufacturers Association. The agency is also publishing the 
recommendation of the Orthopedic and Rehabilitation Devices Panel (the 
Panel) regarding the

[[Page 46564]]

classification of this device. After considering public comments on the 
proposed classification, FDA will publish a final regulation 
classifying this device. This action is being taken 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 
Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the 
Federal Register, FDA is publishing a notice of availability of a draft 
guidance document that would serve as the special control if this 
proposal becomes final.

DATES: Submit written or electronic comments by December 5, 2001. See 
section XIII of this document for the proposed effective date of a 
final rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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 (Regulatory Authorities)

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public 
Law 105-115), 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: (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 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: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by FDAMA; or (3) FDA issues an order finding the 
device to be substantially equivalent, in accordance with 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 of the regulations (21 CFR part 807).
    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 preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``new information.'' The 
reclassification can be initiated by FDA or by the petition of an 
interested person. 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 at 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2 177 (7th Cir. 1966).
    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.) 
Regardless of whether data before the agency are past or new data, the 
``new information'' upon which reclassification under section 513(e) of 
the act is based must consist of ``valid scientific evidence,'' as 
defined in section 513(a)(3) 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. For the purpose of reclassification, 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).)

II. Regulatory History of the Device

    In the Federal Register of September 4, 1987 (52 FR 33686), FDA 
issued a final rule classifying the hip joint metal/polymer constrained 
cemented or uncemented prosthesis into class III (21 CFR 888.3310). The 
preamble to the proposal to classify the device (47 FR 29052, July 2, 
1982) included the recommendation of the Orthopedic Device Section of 
the Surgical and Rehabilitation Devices Panel (the Orthopedic Section 
of the Panel or the Panel), a FDA advisory committee that met regarding 
the classification of the device. The Orthopedic Section of the Panel 
recommended that the device be classified into class III because the 
device is implanted and intended to relieve disabling pain and to 
restore or minimize further loss of functional use of the hip joint or 
limb.
    The Orthopedic Section of the Panel identified the following three 
risks to health associated with use of the device: (1) Loss or 
reduction of joint function, (2) adverse tissue reaction, and (3) 
infection. Improper design or inadequate mechanical properties of the 
device, such as a lack of strength and resistance to wear, may result 
in a loss or reduction of joint function due to excessive wear, 
fracture, device deformation, or loosening of the device. Inadequate 
biological or mechanical properties of the device, such as its lack of 
biocompatibility and resistance to wear, may result in an adverse 
tissue reaction due to dissolution or wearing away of material from the 
surface of the device and the subsequent release of material into the 
surrounding tissues and systemic circulation. The

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implantation of the device may also lead to an increased risk of 
infection.
    FDA agreed with the classification recommendation of the Orthopedic 
Section of the Panel. The preamble to the final rule classifying the 
device into class III advised that the earliest date by which PMA's for 
the device could be required was March 30, 1990, or 90 days after 
issuance of a rule requiring premarket approval for the device, 
whichever occurred later.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA 
categorized the hip joint metal/polymer constrained cemented or 
uncemented prosthesis as a group 1 device that FDA believed had fallen 
into disuse or limited use. FDA believed that rulemaking under section 
515(b) of the act was unlikely to result in viable PMAs or 
reclassification petitions for the device. In the Federal Register of 
September 7, 1995 (60 FR 46718), FDA published a proposed rule to 
require the filing of a PMA or notice of completion of a product 
development protocol (PDP) for 43 preamendments class III medical 
devices, including the hip joint metal/polymer constrained cemented or 
uncemented prosthesis. The agency received no comments regarding the 
proposed rule for the device. In the Federal Register of September 27, 
1996 (61 FR 50704), FDA published a final rule requiring PMAs or PDPs 
for 41 of the class III devices, including the hip joint metal/polymer 
constrained cemented or uncemented prosthesis by December 26, 1996.
    In December 1996, FDA received two PMAs for the device. On December 
13, 1996, Howmedica Osteonics Corp. submitted a PMA for the Osteonics 
Constrained Hip Acetabular Insert. On December 26, 1996, Depuy, 
Orthopaedics, Inc. (Depuy), submitted a PMA for the S-Rom Poly-Dial 
Constrained Liner. Consistent with the act and the regulations, FDA 
consulted with the Panel regarding the approvability of the two PMAs. 
At a public meeting on June 10, 1997, the Panel unanimously recommended 
both PMAs for approval with conditions. In its deliberations on both 
PMAs, the Panel noted the long use of the device and the acceptable 
rate of complications associated with its use. FDA agreed with the 
Panel's recommendations and approved the Howmedica Osteonics Corp. 
Osteonics Constrained Hip Acetabular Insert on June 13, 1997, and the 
Depuy S-Rom Poly-Dial Constrained Liner on June 19, 1997.
    On June 9, 1999, the agency filed a reclassification petition for 
the hip joint metal/polymer constrained cemented or uncemented 
prosthesis from OSMA that was dated June 1, 1999, and amended on June 8 
and August 27, 1999. The petition requested that the device be 
reclassified from class III into class II. The petition included new 
information that was not available in 1996 when the final rule 
requiring PMAs or PDPs for the device was issued. Consistent with the 
act and the regulations, FDA consulted with the Panel regarding the 
possible reclassification of this device.

III. Device Description

    The following revised device description is based on the Panel's 
recommendations and the agency's review:
    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 (21 CFR 888.3027).
    This revised identification more accurately describes the currently 
marketed hip joint metal/polymer constrained cemented or uncemented 
prosthesis.

IV. Recommendation of the Panel

    At a public meeting on November 4, 1999, the Panel recommended that 
the hip joint metal/polymer constrained cemented or uncemented 
prosthesis intended to replace a hip joint be reclassified from class 
III into class II (Ref. 2). The Panel believed that class II with 
special controls would provide reasonable assurance of the safety and 
effectiveness of the device.

V. Risks to Health

    After considering the information in the petition, the Panel's 
deliberations, the published literature, and the Medical Device 
Reports, FDA has evaluated the risks to health associated with the use 
of the hip joint metal/polymer constrained cemented or uncemented 
prosthesis. FDA now believes that the following are risks to health 
associated with use of the device: Infection, adverse tissue reaction, 
pain and/or loss of function, and revision. FDA notes that these risks 
to health are also associated with the use of other hip joint 
prostheses. In section VIII of this document, FDA describes a class II 
special controls guidance that addresses these risks to health.

A. Infection

    Infection is a potential risk to health associated with all 
surgical procedures and implanted devices, and it occurs in patients 
implanted with metal/polymer constrained hip joint prostheses (Ref. 1). 
The best defenses against infection are preventive measures, including 
selection of patients without known local and/or systemic infection, 
administration of perioperative antibiotics, implantation of a 
sterilized device, and strict adherence to sterile surgical technique.

B. Adverse Tissue Reaction

    Adverse tissue reaction is a potential risk to health associated 
with all implanted devices (Ref. 1). If the materials used in the 
manufacture of metal/polymer constrained hip joint prostheses are not 
biocompatible or adequately wear resistant, the patient could have an 
adverse tissue reaction.

C. Pain and/or Loss of Function

    Pain and loss of hip joint function can occur with any hip 
arthroplasty. Loosening due to inappropriate patient and/or device 
selection; inappropriate surgical technique and/or poor bone quality; 
metal and/or polyethylene wear that may cause osteolysis (dissolution 
of bone); dislocation and instability due to inappropriate surgical 
technique and/or component design or failure; and component disassembly 
(e.g., disengagement of the metal reinforcing ring from the outer rim 
of the acetabular cup), fracture, and/or failure are potential 
complications that may result in pain and/or loss of hip joint 
function. In addition, because the constrained total hip prosthesis has 
components that are linked together across the joint, there is 
typically a reduction in the range of hip joint motion compared to a 
semi-constrained total hip prosthesis.

D. Revision

    Revision is a potential risk to health associated with any hip 
arthroplasty. The major causes for revision of the metal/polymer 
constrained hip joint prosthesis are infection, adverse tissue 
reaction, and pain and/or loss of function. Revision hip arthroplasty 
typically has a lower clinical success rate than primary hip 
arthroplasty.

VI. Summary of Reasons for Recommendation

    After considering the information in the petition and provided by 
FDA, the discussion during the Panel meeting,

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and their personal knowledge of and clinical experience with the 
device, the Panel gave two reasons in support of its recommendation to 
classify the generic type hip joint metal/polymer constrained cemented 
or uncemented prosthesis intended to replace a hip joint from class III 
into class II. The Panel believed the device should be classified into 
class II because special controls, in addition to general controls, 
would provide reasonable assurance of the safety and effectiveness of 
the device, and there is sufficient information to establish special 
controls to provide such assurance.

VII. Summary of the Data Upon Which the Recommendation is Based

    In addition to the potential risks to health of the hip joint 
metal/polymer constrained cemented or uncemented prosthesis described 
in section V of this document, there is reasonable knowledge of the 
benefits of the device (Ref.1). The device provides decreased pain or 
cessation of pain and increased mobility and function, resulting in an 
overall improved quality of patient life. In addition, the device may 
help to reduce the recurrence of dislocation. Based on the available 
information, FDA believes the special control discussed in section VIII 
of this document is capable of providing reasonable assurance of the 
safety and effectiveness of the device with regard to the identified 
risks to health of the device.

VIII. Special Controls

    FDA believes that, in addition to general controls, the class II 
special controls guidance document entitled ``Class II Special Controls 
Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented 
Prosthesis'' (the class II special controls guidance) is an adequate 
special control to address the risks to health described in section V 
of this document. The class II special controls guidance provides 
information on how to meet premarket notification (510(k)) submission 
requirements for the device, including a list of relevant FDA 
orthopedic device guidance documents, voluntary consensus standards 
from the American Society for Testing and Materials and International 
Organization for Standardization, and labeling statements. Elsewhere in 
this issue of the Federal Register, FDA is publishing a notice of 
availability of this guidance document that FDA intends to use as the 
special control for this device.
    The FDA guidance documents identified in the class II special 
controls guidance provide information on how to meet general orthopedic 
device premarket notification (510(k)) requirements, including 
biocompatibility testing, sterility testing, mechanical performance 
testing, and labeling. The FDA guidance documents can help control the 
risks to health of infection, adverse tissue reaction, pain and/or loss 
of function, and revision by having manufacturers address the need to 
use surgical quality implant materials, adequately test and sterilize 
their devices, and provide adequate instructions for use.
    The voluntary consensus standards identified in the class II 
special controls guidance for the device define implant material 
specifications, testing methods, and performance criteria applicable to 
the hip joint metal/polymer constrained cemented or uncemented 
prosthesis. Adherence to these standards and comparison of the results 
from these test methods can control the risks of adverse tissue 
reaction, pain and/or loss of function, and revision by having 
manufacturers use surgical quality implant materials, adequately test 
their devices, and assure that the device has acceptable mechanical 
performance.
    The labeling information listed in the class II special controls 
guidance identifies the intended use, specific indications for use, and 
precautions for use of the device. Adequate instructions for use by 
manufacturers can control the risks to health of adverse tissue 
reaction, pain and/or loss of function, and revision.

IX. FDA's Tentative Findings

    FDA believes that the hip joint metal/polymer constrained cemented 
or uncemented prosthesis intended to replace a hip joint should be 
classified into class II because special controls, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the device and there is sufficient information to 
establish special controls to provide such assurance.

X. Environmental Impact

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

XI. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 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 proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, the proposed 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. Because the proposed rule classifying this device 
into class II will relieve all manufacturers of the device from the 
cost of complying with the premarket approval requirements in section 
515 of the act, it will impose no significant economic impact on any 
small entities. The agency therefore certifies that this proposed rule, 
if finalized, will not have a significant economic impact on a 
substantial number of small entities. In addition, this proposed rule 
will not impose costs of $100 million or more on either the private 
sector or State, local, and 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.

XII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
information that is subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995. The proposed special 
control does not require the respondent to submit additional 
information.

XIII. Submission of Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this proposal 
by December 5, 2001. Two copies of any comments are to be submitted 
except that individuals may submit one 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 office above 
between 9 a.m. and 4 p.m., Monday through Friday. FDA proposes that any 
final regulation

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that may issue based on this proposal become effective 30 days after 
its publication in the Federal Register.

XIV. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday,
    1. Petition for the reclassification of hip joint metal/polymer 
constrained cemented or uncemented prosthesis submitted by the 
Orthopedic Surgical Manufacturers Association, Warsaw, IN, dated 
June 1, 1999, amended June 8 and August 27, 1999.
    2. Transcript of the Orthopedic and Rehabilitation Devices Panel 
Meeting, November 4, 1999, pp. 25 to 142.

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). This 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: August 22, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-22286 Filed 9-5-01; 8:45 am]
BILLING CODE 4160-01-S