[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