[Federal Register Volume 68, Number 56 (Monday, March 24, 2003)]
[Rules and Regulations]
[Pages 14134-14138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 00N-0018]


Medical Devices; Reclassification of the Knee Joint 
Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis 
and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer 
Porous-Coated Uncemented Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 14135]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has reclassified two fixed-bearing knee joint prostheses, the knee 
joint patellofemorotibial metal/polymer porous-coated uncemented 
prosthesis, which is intended to be implanted to replace a knee joint, 
and the knee joint femorotibial (uni-compartmental) metal/polymer 
porous-coated uncemented prosthesis, which is intended to be implanted 
to replace part of a knee joint. FDA has reclassified the devices from 
class III (premarket approval) into class II (special controls). The 
special control that will apply is a guidance document entitled ``Class 
II Special Controls Guidance Document: Knee Joint Patellofemorotibial 
and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; 
Guidance for Industry and FDA.'' The agency is reclassifying these 
devices into class II because special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the devices, and there is sufficient information to 
establish special controls. The agency is also announcing that it has 
issued an order in the form of a letter to the Orthopedic Surgical 
Manufacturers Association (OSMA) reclassifying the devices.

EFFECTIVE DATE: This rule is effective March 24, 2003.

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

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (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 (21 U.S.C. 
360c(f)) 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 section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)); or (3) FDA 
issues an order finding the device to be substantially equivalent, 
under section 513(i) of the act (21 U.S.C. 360c(i)), 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 (510(k)) 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 postamendments devices is governed by section 
513(f)(3) of the act (21 U.S.C.360c(f)(3)). This section states that 
FDA may initiate the reclassification of a device classified into class 
III under section 513(f)(1) of the act, or that a manufacturer or 
importer of a device may petition the Secretary of Health and Human 
Services (the Secretary) for the issuance of an order classifying the 
device into class I or class II. FDA's regulations in 21 CFR 860.134 
set forth the procedures for the filing and review of a petition for 
reclassification of such class III devices. In order to change the 
classification of the device, it is necessary that the proposed new 
class have sufficient regulatory controls to provide reasonable 
assurance of the safety and effectiveness of the device for its 
intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may, for 
good cause shown, refer a petition to a device panel. If a petition is 
referred to a panel, the panel shall make a recommendation to the 
Secretary respecting approval or denial of the petition. Any such 
recommendation shall contain: (1) A summary of the reasons for the 
recommendation, (2) a summary of the data upon which the recommendation 
is based, and (3) an identification of the risks to health (if any) 
presented by the device with respect to which the petition was filed.

II. Recommendations of the Panel

    On July 25, 1997, FDA filed a reclassification petition submitted 
by OSMA, requesting reclassification of the knee joint 
patellofemorotibial metal/polymer porous-coated uncemented prosthesis, 
which is intended to be implanted to replace a knee joint, and the knee 
joint femorotibial (uni-compartmental) metal/polymer porous-coated 
uncemented prosthesis, which is intended to be implanted to replace 
part of a knee joint, from class III into class II. FDA consulted with 
the Orthopedic and Rehabilitation Devices Panel (the Panel) regarding 
the reclassification petition. During a public meeting on January 12 
and 13, 1998, the Panel recommended that FDA reclassify these two 
devices from class III into class II. The Panel recommended that the 
special controls for these devices be FDA guidance documents, consensus 
standards, and postmarket surveillance.
    FDA considered the Panel's recommendation and tentatively agreed 
that these generic types of devices should be reclassified from class 
III to class II. FDA agreed with the Panel that guidance documents, 
which include the consensus standards, are appropriate special controls 
for the devices.
    FDA disagreed with the Panel that postmarket surveillance, under 
section 522 of the act (21 U.S.C. 3601), is an appropriate special 
control for these devices. In their deliberations, the Panel stated 
that it was important that adverse device outcomes be reported to FDA 
and be followed through postmarket surveillance. However, FDA believes 
that another postmarket mechanism better addresses the Panel's concern. 
FDA believes that the existing mandatory Medical Device Reporting 
system is the appropriate mechanism to report and follow such adverse 
events. Therefore, FDA determined that postmarket surveillance under 
section 522 of the act is unnecessary to address the Panel's concerns 
and to reasonably

[[Page 14136]]

assure the safety and effectiveness of the devices.
    Subsequently, in the Federal Register of March 7, 2000 (65 FR 
12015), FDA issued the Panel's recommendation for public comment. FDA 
received three comments on the notice of panel's recommendation that 
supported the Panel's recommendation to reclassify the devices into 
class II. FDA agrees with these comments.
    One comment also requested the following three changes in the 
device identification:
    (1) Change the proposed porous coating thickness range from 600 to 
1,500 microns to 500 to 1,600 microns ``to increase the potential for 
bone ingrowth.''
    (2) Change the proposed volume porosity percentage range from 30 to 
70 percent to 30 to 80 percent based upon a transcortical animal study 
model that demonstrated more bone formation occurred with the use of 
higher volume porosity materials than with the use of lower volume 
porosity materials
    (3) Include in the device identifications a statement that a new 
coating material that meets the identification parameters (volume 
porosity, average pore size, interconnecting porosity, and porous 
coating thickness) and has equivalent performance (demonstrated by 
mechanical testing and/or animal studies) can be determined to be 
substantially equivalent to a legally currently marketed device without 
human clinical information.
    FDA agrees that the lower limit of the porous-coating thickness 
should be 500 microns not 600 microns. The lower limit of the Panel's 
recommendation was 500 microns, but due to a typographical error a 
lower limit of 600 microns was printed in the notice of panel 
recommendation. FDA is noting and correcting this error. FDA disagrees 
with the request to raise the upper limit of the porous coating 
thickness range to 1,600 microns because the comment did not provide 
any data to support this requested change. FDA notes that a higher 
porous coating thickness is not necessarily excluded and that a sponsor 
of a new device may submit material characterization information to 
demonstrate that a device with a thicker porous coating material is 
substantially equivalent to a legally marketed predicate device.
    FDA disagrees with the comment that suggested a change in the 
volume porosity percentage range in the identifications because the 
agency does not believe that a single animal study is sufficient to 
demonstrate in vivo performance of joint replacement devices in humans. 
FDA also notes that a material with a higher porosity is not 
necessarily excluded and that a sponsor of a new device may submit 
material characterization information to demonstrate that a more porous 
material is substantially equivalent to a legally marketed predicate 
device.
    FDA disagrees with the comment that suggested that the 
identifications should allow for a change to a new material that is 
comparable, because this addition to the identifications is 
unnecessary. The device identifications do not exclude the use of new 
materials in devices whose safety and effectiveness performance can be 
demonstrated to be substantially equivalent to legally marketed 
devices.
    Based on consideration of this comment and reevaluation of 
previously cleared orthopedic joint prostheses, FDA has revised the 
device identifications published in the notice of panel recommendation. 
FDA has determined that the words metal and polymer adequately define 
the material composition of the devices and that it is unnecessary to 
list in the device identifications all the types of metals and polymers 
in legally marketed devices of these types. FDA has also removed the 
porous coating characteristics from the device identifications in the 
notice of panel recommendation because it is also unnecessary to list 
porous coating characteristics ranges in the device identifications. 
FDA has concluded that it is more appropriate to describe materials and 
porous coating characteristics in the class II special controls 
guidance document. FDA notes that guidance documents can be updated 
after applicants demonstrate that devices with new materials are 
substantially equivalent legally marketed devices.

III. FDA's Conclusion

    After reviewing the data in the petition and presented at the Panel 
meeting, and after considering the Panel's recommendation and the 
comments on the notice of panel recommendation, FDA has determined that 
the knee joint patellofemorotibial metal/polymer porous-coated 
uncemented prosthesis, which is intended to be implanted to replace a 
knee joint, and the knee joint femorotibial (uni-compartmental) metal/
polymer porous-coated uncemented prosthesis, which is intended to be 
implanted to replace part of a knee joint, can be reclassified from 
class III into class II.
    On February 3, 2003, FDA issued an order to the petitioner 
reclassifying the devices into class II (special controls). The order 
also identified the special control applicable to these devices as a 
guidance document entitled ``Class II Special Controls Guidance 
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer 
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.'' 
The class II special controls guidance document incorporates the 4 FDA 
guidance documents and the 11 American Society for Testing Materials 
(ASTM) consensus standards that were identified as proposed special 
controls for the devices in the notice of panel recommendation. FDA 
notes that the class II special controls guidance document includes the 
updated ASTM consensus standards. FDA has also incorporated into the 
class II special controls guidance document one additional FDA guidance 
document, 16 additional ASTM consensus standards, and 11 International 
Organization for Standardization (ISO) consensus standards. This class 
II special controls guidance document is now the special control for 
these devices.
    An alternative approach to the special controls guidance document 
may be used if such approach satisfies the applicable statute and 
regulations. Following the effective date of this final classification 
rule, any firm submitting a 510(k) premarket notification for one of 
these devices will need to address the issues covered in the special 
control guidance. However, the firm need only show that its device 
meets the recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness.
    Accordingly, as required by 21 CFR 860.134(b)(6) and (b)(7) of the 
regulations, FDA is announcing the reclassification of the generic knee 
joint patellofemorotibial metal/polymer porous-coated uncemented 
prosthesis, which is intended to be implanted to replace a knee joint, 
and the knee joint femorotibial (uni-compartmental) metal/polymer 
porous-coated uncemented prosthesis, which is intended to be implanted 
to replace part of a knee joint, from class III into class II. In 
addition, FDA is issuing this final rule to codify the reclassification 
of the device by adding new Sec. Sec.  888.3565 and 888.3535.

IV. Electronic Access

    In order to receive the guidance document entitled ``Class II 
Special Controls Guidance Document: Knee Joint Patellofemorotibial and 
Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; 
Guidance for Industry and FDA'' via your fax machine, call the CDRH 
Facts-

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On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order the document. Enter the document number 1418 followed 
by the pound sign ([numsign]). Follow the remaining prompts to complete 
your request.
    Persons interested in obtaining a copy of the FDA guidance document 
may do so using the Internet. The Center for Devices and Radiological 
Health (CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer. Updated on a regular basis, the CDRH home page 
includes device safety alerts, Federal Register reprints, information 
on premarket submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. You may access the CDRH home 
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance 
documents at http://www.gfa.gov/cdrh/guidance.html. Guidance documents 
are also available at http://www/fda.gov/ohrms/dockets.

V. Environmental Impact

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

VI. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 these devices from class III to 
class II will relieve all manufacturers of the devices of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. 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 $110 million or more on either the 
private sector or state, local, and tribal governments in the 
aggregate, and, therefore, a summary statement or analysis pursuant to 
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

VII. Federalism

    FDA has analyzed this final rule in accordance with 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 this final rule does not 
contain policies that have federalism implications as defined in the 
order and, consequently, a federalism summary impact statement is not 
required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (Public Law. 104-13) 
is not required.

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, 21 CFR 
part 888 is 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 888.1 is amended by adding paragraph (e) to read as 
follows:


Sec.  888.1  Scope

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.
    3. Section 888.3535 is added to subpart D to read as follows:


Sec.  888.3535  Knee joint femorotibial (uni-compartmental) metal/
polymer porous-coated uncemented prosthesis.

    (a) Identification. A knee joint femorotibial (uni-compartmental) 
metal/polymer porous-coated uncemented prosthesis is a device intended 
to be implanted to replace part of a knee joint. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surface. It has no linkage across-the-joint. This generic 
type of device is designed to achieve biological fixation to bone 
without the use of bone cement. This identification includes fixed-
bearing knee prostheses where the ultra-high molecular weight 
polyethylene tibial bearing is rigidly secured to the metal tibial 
baseplate.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance: ``Class II Special Controls Guidance 
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer 
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.'' 
See Sec.  888.1 for the availability of this guidance.
    4. Section 888.3565 is added to subpart D to read as follows:


Sec.  888.3565   Knee joint patellofemorotibial metal/polymer porous-
coated uncemented prosthesis.

    (a) Identification. A knee joint patellofemorotibial metal/polymer 
porous-coated uncemented prosthesis is a device intended to be 
implanted to replace a knee joint. The device limits translation and 
rotation in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across-the-joint. This generic type of 
device is designed to achieve biological fixation to bone without the 
use of bone cement. This identification includes fixed-bearing knee 
prostheses where the ultra high molecular weight polyethylene tibial 
bearing is rigidly secured to the metal tibial base plate.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance: ``Class II Special Controls Guidance 
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer 
Porous-Coated Uncemented Prostheses; Guidance for

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Industry and FDA.'' See Sec.  888.1 for the availability of this 
guidance.

    Dated: March 10, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health
[FR Doc. 03-6857 Filed 3-21-03; 8:45 am]
BILLING CODE 4160-01-S