[Federal Register Volume 66, Number 40 (Wednesday, February 28, 2001)]
[Rules and Regulations]
[Pages 12734-12737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 97P-0354]


Medical Devices; Reclassification of the Shoulder Joint Metal/
Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated 
Uncemented Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is reclassifying the shoulder joint metal/polymer/metal nonconstrained 
or semi-constrained porous-coated uncemented prosthesis intended to 
replace a shoulder joint from class III to class II (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 device. The special control that will apply is a 
guidance document entitled ``Class II Special Controls Guidance: 
Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained 
Porous-Coated Uncemented Prosthesis.'' The agency is classifying this 
device 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.

[[Page 12735]]


DATES: This rule is effective March 30, 2001.

FOR FURTHER INFORMATION CONTACT: Theodore R. Stevens, 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 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 (the 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 the 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 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 postamendments devices is governed by section 
513(f)(3) of the act, formerly section 513(f)(2) of the act. This 
section provides that FDA may initiate the reclassification of a device 
classified into class III under section 513(f)(1) of the act, or the 
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 in class I or class II. FDA's regulations in 
Sec. 860.134 (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.
    The FDAMA added a new section 513(f)(2) to the act which addresses 
classification of postamendments devices. New section 513(f)(2) of the 
act provides that, upon receipt of a ``not substantially equivalent'' 
determination, a 510(k) applicant may request FDA to classify a 
postamendments device into class I or class II. Within 60 days from the 
date of such a written request, FDA must classify the device by written 
order. If FDA classifies the device into class I or II, the applicant 
has then received clearance to market the device, and it can be used as 
a predicate device for other 510(k)'s. It is expected that this process 
will be used for low risk devices. This process does not apply to 
devices that have been classified by regulation into class III, i.e., 
preamendments class III devices, or class III devices for which a PMA 
is appropriate.
    Under section 513(f)(3)(B)(i) of the act, formerly section 
513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, 
refer a petition to a device classification 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. Recommendation of the Panel

    On July 23, 1997, FDA filed the reclassification petition submitted 
by OSMA, requesting reclassification of the shoulder joint metal/
polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis intended to replace a shoulder joint from class 
III to class II. FDA consulted with the Orthopedic and Rehabilitation 
Devices Panel (the Panel) regarding the reclassification petition. 
During an open public meeting on January 12 and 13, 1998, the Panel 
recommended that FDA reclassify the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
intended to replace a shoulder joint from class III to class II. The 
Panel recommended that the special controls for the device be FDA 
guidance documents, consensus standards, and postmarket surveillance.
    FDA considered the Panel's recommendation and tentatively agreed 
that the generic type of device, the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
intended to replace a shoulder joint, be reclassified from class III to 
class II. FDA agrees that guidance documents and consensus standards 
are appropriate special controls for the device.
    FDA disagrees with the Panel that postmarket surveillance is a 
necessary or an appropriate special control for the device. In their 
deliberations, the Panel stated that it was important that adverse 
device outcomes should be reported to FDA and should be tracked through 
postmarket surveillance. 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 such adverse events. Therefore, postmarket surveillance is 
unnecessary to address the Panel's concerns and to reasonably assure 
the safety and effectiveness of the device.
    Subsequently, in the Federal Register of May 28, 1999 (64 FR 
29043), FDA issued the Panel's recommendation for public comment. FDA 
received two comments on the Panel's recommendation. Both comments 
supported the Panel's recommendation

[[Page 12736]]

to reclassify the device into class II. One comment also provided 
updated information on the designations (years of issuance) and the 
titles for six of the American Society for Testing and Materials (ASTM) 
consensus standard special controls for the device. FDA agrees with 
these comments and will incorporate the updated designations and titles 
in the special control for the device.
    After reviewing the data in the petition and presented before the 
Panel, and after considering the Panel's recommendation and the 
comments on the notice of panel recommendation, FDA issued an order to 
the petitioner on December 17, 1999, reclassifying the shoulder joint 
metal/polymer/metal nonconstrained or semi-constrained porous-coated 
uncemented prosthesis intended to replace a shoulder joint, and 
substantially equivalent devices of this generic type, from class III 
to class II with the implementation of special controls.
    The special controls listed in the order to the petitioner were FDA 
guidance documents and consensus standards. The FDA guidance documents 
were as follows:
    1. ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement;''
    2. ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components;''
    3. ``Draft Guidance Document for the Preparation of Premarket 
Notification (510(k)) Applications for Orthopedic Devices-The Basic 
Elements;''
    4. ``Use of International Standard ISO-10993, `Biological 
Evaluation of Medical Devices Part 1: Evaluation and Testing;''' and
    5. ``510(k) Sterility Review Guidance (# K90-1),'' 2/12/90.
    The ASTM consensus standards were as follows:
    1. F 67-95, ``Standard Specifications for Unalloyed Titanium for 
Surgical Implant Applications;''
    2. F 75-98, ``Standard Specification for Cobalt-28 Chromium-6 
Molybdenum Casting Alloy and Cast Products for Surgical Implants (UNS 
R30075);''
    3. F 136-98, ``Standard Specification for Wrought Titanium-6 
Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy (UNS R56401)) for 
Surgical Implant Applications;''
    4. F 648-98, ``Standard Specification for Ultra-High Molecular 
Weight Polyethylene Powder and Fabricated Form for Surgical Implants;''
    5. F 1044-95, ``Standard Test Method for Shear Testing of Porous 
Metal Coatings;''
    6. F 1147-99, ``Standard Test Method for Tension Testing of Calcium 
Phosphate and Metallic Coatings;''
    7. F 1160-98, ``Standard Test Method for Shear and Bending Fatigue 
Testing of Calcium Phosphate and Metallic Medical Coatings;''
    8. F 1377-98a, ``Standard Specification for Cobalt-28 Chromium-6 
Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075);''
    9. F 1378-99, ``Standard Specification for Shoulder Prostheses;'' 
and
    10. F 1580-95, ``Standard Specification for Titanium and Titanium-
6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical 
Implants.''
    FDA has recently incorporated the 5 FDA guidance documents and the 
10 ASTM consensus standards into a special control guidance entitled 
``Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/
Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented 
Prosthesis.'' This guidance document is now the special control for 
this generic device.
    Accordingly, as required by Sec. 860.134(b)(6) and (b)(7) of the 
regulations, FDA is announcing the reclassification of the generic 
shoulder joint metal/polymer/metal nonconstrained or semi-constrained 
porous-coated uncemented prosthesis intended to replace a shoulder 
joint from class III into class II. On December 17, 1999, FDA issued an 
order to OSMA reclassifying the shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
into class II. In addition, FDA is issuing this final rule to codify 
the reclassification of the device by adding new Sec. 888.3670.

III. Access to Special Controls

    Persons interested in obtaining a copy of an FDA guidance 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 with access to the Internet. The CDRH home page 
may be accessed at http://www.fda.gov/cdrh . Guidance documents are 
also available from the Division of Small Manufacturers Assistance 
(DSMA) (HFZ-220), Food and Drug Administration, Center for Devices and 
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. In order to 
receive the FDA guidance documents via your fax machine call the CDRH 
Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system and enter the 
document number followed by the pound sign (#). Follow the remaining 
voice prompts to complete your request. The document number is 1193 for 
``Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/
Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented 
Prosthesis.''

IV. 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.

V. 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 the device from class III to 
class II will relieve all manufacturers of the device 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 this device, 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 $100 million or more on either the 
private sector or

[[Page 12737]]

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.

VI. 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 order and, consequently, a federalism 
summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 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 888.3670 is added to subpart D to read as follows:


Sec. 888.3670  Shoulder joint metal/polymer/metal nonconstrained or 
semi-constrained porous-coated uncemented prosthesis.

    (a) Identification. A shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
is a device intended to be implanted to replace a shoulder joint. The 
device limits movement in one or more planes. It has no linkage across-
the-joint. This generic type of device includes prostheses that have a 
humeral component made of alloys such as cobalt-chromium-molybdenum 
(Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a 
glenoid resurfacing component made of ultra-high molecular weight 
polyethylene, or a combination of an articulating ultra-high molecular 
weight bearing surface fixed in a metal shell made of alloys such as 
Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have 
a porous coating made of, in the case of Co-Cr-Mo components, beads of 
the same alloy or commercially pure titanium powder, and in the case of 
Ti-6Al-4V components, beads or fibers of commercially pure titanium or 
Ti-6Al-4V alloy, or commercially pure titanium powder. The porous 
coating has a volume porosity between 30 and 70 percent, an average 
pore size between 100 and 1,000 microns, interconnecting porosity, and 
a porous coating thickness between 500 and 1,500 microns. This generic 
type of device is designed to achieve biological fixation to bone 
without the use of bone cement.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance: 
Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained 
Porous-Coated Uncemented Prosthesis.''

    Dated: February 4, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-4846 Filed 2-27-01; 8:45 am]
BILLING CODE 4160-01-F