[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Federal Register, FDA is publishing a notice of availability of a draft
guidance document that would serve as the special control if this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