[Federal Register Volume 67, Number 173 (Friday, September 6, 2002)]
[Notices]
[Pages 57024-57026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22688]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01P-0343]


Orthopedic Devices; Denial of Request for Change in 
Classification of Hip Joint Metal/Metal Semi-Constrained, With a 
Cemented Acetabular Component, Prosthesis and Hip Joint Metal/Metal 
Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; denial of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is denying the petition 
submitted by the Orthopedic Surgical Manufacturers Association (OSMA) 
to reclassify the hip joint metal/metal semi-constrained prosthesis 
with a cemented acetabular component and the hip joint metal/metal 
semi-constrained prosthesis with an uncemented acetabular component 
from class III (premarket approval) into class II (special controls). 
The agency is denying the petition because OSMA failed to provide any 
new information to establish that special controls would provide 
reasonable assurance of the safety and effectiveness of the devices. 
The agency is also publishing the recommendation of FDA's Orthopedic 
and Rehabilitation Devices Panel (the Panel) concerning the petition. 
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).

FOR FURTHER INFORMATION CONTACT: Glenn A. Stiegman, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2036.

SUPPLEMENTARY INFORMATION:

I. Classification and Reclassification of Devices Under the Amendments

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), 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). Except as provided in section 
520(c) of the act (21 U.S.C. 360j(c)), FDA may not use confidential 
information concerning a device's safety and effectiveness as a basis 
for reclassification of the device from class III into class II or 
class I.
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 
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 preamendment 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, 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 marketed devices by means of premarket notification 
procedures in

[[Page 57025]]

section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the 
regulations.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section of the act provides that FDA 
may, by rulemaking, reclassify a device (in a proceeding that parallels 
the initial classification proceeding) based on ``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) and 515(b)(2)(A)(iv) of the act (21 U.S.C. 360e(b)(2)(A)(iv)), 
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).)
    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 Upjohnv. 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) of the act and Sec.  860.7(c)(2) (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 
premarket approval application (PMA). (See section 520(c) of the act.)

II. Background

    In the Federal Register of September 4, 1987 (52 FR 33686 at 
33706), FDA issued a final rule classifying the hip joint metal/metal 
semi-constrained prosthesis with a cemented acetabular component and 
the hip joint metal/metal semi-constrained prosthesis with an 
uncemented acetabular component, (the hip joint metal/metal semi-
constrained prostheses) into class III (21 CFR 888.3330 and 888.3320, 
respectively). In the preamble to the proposal to classify these 
devices (47 FR 29052, July 2, 1982), the Panel identified the following 
risks to health associated with use of the devices: Loss or reduction 
of joint function, adverse tissue reactions, and infection.
    In the Federal Register of January 6, 1989 (54 FR 550), FDA 
published a notice of intent to initiate proceedings to require 
premarket approval for the hip joint metal/metal semi-constrained 
prostheses. FDA updated its priorities in the preamendments class III 
strategy notice of availability published in the Federal Register of 
May 6, 1994 (59 FR 23731). The agency categorized the hip joint metal/
metal semi-constrained prostheses as high priority group 3 devices, 
devices the agency considered to have a low probability of being 
reclassified into class I or class II. FDA has determined that the 
devices identified have a high priority for initiating a proceeding to 
require premarket approval.
    On September 25, 2000, FDA received a petition (Ref. 1) from OSMA 
requesting that the classification of hip joint metal/metal semi-
constrained prostheses be changed from class III into class II.

III. Device Descriptions

    FDA has identified the hip joint, metal/metal semi-constrained 
prosthesis with a cemented acetabular component and the hip joint, 
metal/metal semi-constrained prosthesis with a cemented acetabular 
component as follows: A hip joint metal/metal semi-constrained 
prosthesis with a cemented acetabular component, prosthesis is a two 
part device intended to be implanted to replace a hip joint. The device 
limits translation and rotation in one or more planes via the geometry 
of its articulation surfaces. It has no linkage across-the-joint. This 
generic type of device includes prostheses that consist of a femoral 
and an acetabular component, both made of alloys, such as cobalt-
chromium-molybdenum. This generic type of device is limited to those 
prostheses intended for use with bone cement.
    A hip joint metal/metal semi-constrained prosthesis with an 
uncemented acetabular component is a two part device intended to be 
implanted to replace a hip joint. The device limits translation and 
rotation in one or more planes via the geometry of its articulation 
surfaces. It has no linkage across-the-joint. This generic type of 
device includes prostheses that consist of a femoral and an acetabular 
component, both made of alloys, such as cobalt-chromium-molybdenum. 
This generic type of device is limited to those prostheses intended for 
use without bone cement.

IV. Recommendation of the Panel

    In a public meeting on August 8, 2001, the Panel recommended five 
to two that the hip joint metal/metal semi-constrained prostheses not 
be reclassified from class III into class II (Ref. 2). The Panel 
concluded that the information in the petition did not demonstrate that 
special controls would provide reasonable assurance of safety and 
effectiveness of the device and that there was not sufficient 
information to establish special controls for the device. Specifically, 
the Panel determined that there was insufficient clinical and 
preclinical testing information to establish special controls. The 
Panel concluded that the length and rate of the long-term patient 
followup data were inadequate to demonstrate that special controls 
would provide reasonable assurance that the devices are safe and 
effective for their intended use. In addition, the Panel discussed that 
preclinical information, including validation of wear simulation, 
nonideal preclinical wear testing, and biological evaluation of 
metallic wear debris generated by the devices were not established. The 
particle size of the metallic wear debris generated by these devices is 
substantially smaller than the particle size of the metallic wear 
debris generated by other hip joint prostheses, and the short- and 
long-term biological effects from human retrievals or preclinical 
evaluation of these smaller-size metallic wear particles, are unknown. 
The Panel believed that premarket approval is necessary for the devices 
because there is insufficient information to establish that special 
controls would provide reasonable assurance of their safety and 
effectiveness.

V. FDA's Conclusion

    Based on its review of the information contained in the petition 
and presented at the Panel meeting, as well as the Panel's discussion, 
the agency concurred with the Panel's recommendations. FDA agrees that 
there is insufficient valid scientific evidence to determine that 
special controls, in addition to the general controls applicable to all 
devices, would provide reasonable assurance of the devices' safety and 
effectiveness for their

[[Page 57026]]

intended use. The agency, therefore, is denying the petition.

VI. Reasons for the Denial

    FDA has determined that the clinical and preclinical information in 
the petition is insufficient to support the requested change in 
classification of these devices. FDA believes that additional clinical 
data, including a longer patient followup time and a higher rate of 
patient followup, are necessary to develop special controls to ensure 
the safety and effectiveness of these devices. The agency believes that 
additional preclinical data, including the validation of hip simulation 
and nonideal wear testing of the devices at extreme loading angles, 
higher than normal loads, and start-stop cyclic loading, are necessary. 
FDA also believes that preclinical evaluation of the response to 
smaller sized metallic wear debris is necessary to establish special 
controls to provide the reasonable assurance of safety and 
effectiveness of the devices. FDA notes that the evaluation of the 
response to wear particles may include the evaluation of retrieved 
human devices.
    In a future issue of the Federal Register, FDA may initiate 
rulemaking under section 515(b) of the act to require premarket 
approval for these devices. FDA notes that if new information becomes 
available, interested persons may submit a new reclassification 
petition for the devices to the agency for evaluation. FDA advises 
manufacturers of these device types to collect the data and information 
necessary to demonstrate reasonable assurance of the safety and 
effectiveness of their devices. This data and information should be in 
the form of valid scientific evidence, as defined by Sec.  860.7, to 
support the least burdensome regulatory path to either remaining on the 
market, or entering the market for the first time. FDA believes that 
early data collection will more likely lead to success in obtaining 
premarket approval or having these device types reclassified.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. These references may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition for Reclassification for Metal/Metal Semi-Constrained 
Hip Joint Prosthesis submitted by the Orthopedic Surgical Manufacturers 
Association, Warsaw, IN, dated September 25, 2000, and amended on 
November 28, 2000, and June 4, 2001.
    2. Transcript of the Orthopedic and Rehabilitation Devices Panel 
Meeting, August 8, 2001, pp. 1 to 244.

    Dated: August 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-22688 Filed 9-5-02; 8:45 am]
BILLING CODE 4160-01-S