[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Rules and Regulations]
[Pages 59132-59134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22210]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 2003N-0561]


Orthopedic Devices; Effective Date of Requirement for Premarket 
Approval for Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained 
Resurfacing Cemented Prosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to require the filing of a premarket approval application (PMA) or a 
notice of completion of a product development protocol (PDP) for the 
hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing 
cemented prosthesis. The agency also is summarizing its proposed 
findings regarding the degree of risk of illness or injury designed to 
be eliminated or reduced by requiring the devices to meet the statute's 
approval requirements and the benefits to the public from the use of 
the devices. This action implements certain statutory requirements.

DATES: This rule is effective October 4, 2004. Under this final rule, a 
PMA or a notice of completion of a PDP is required to be filed on or 
before January 3, 2005, for any hip joint metal/polymer or ceramic/
polymer semiconstrained resurfacing cemented prosthesis.

FOR FURTHER INFORMATION CONTACT: Pei Sung, 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

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 
94-295) and the Safe Medical Devices Act of 1990 (Public Law 101-629), 
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).
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. A preamendments class III 
device may be commercially distributed without an approved PMA or a 
notice of completion of a PDP until 90 days after FDA issues a final 
rule requiring premarket approval for the device, or 30 months after 
final classification of the device under section 513 of the act, 
whichever is later. Also, a preamendments device subject to the 
rulemaking procedure under section 515(b) of the act is not required to 
have an approved investigational device exemption (IDE) (see part 812 
(21 CFR part 812)) contemporaneous with its interstate distribution 
until the date identified by FDA in the final rule requiring the 
submission of a PMA for the device. At that time, an IDE is required 
only if a PMA has not been submitted or a PDP completed.
    When a rule to require premarket approval for a preamendments 
device is finalized, section 501(f)(2)(B) of the act (21 U.S.C. 
351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for 
any such device be filed within 90 days of the date of issuance of the 
final rule or 30 months after the final classification of the device 
under section 513 of the act, whichever is later. If a PMA or notice of 
completion of a PDP is not filed by the latter of the two dates, 
commercial distribution of the device must cease.
    The device may, however, be distributed for investigational use if 
the manufacturer, importer, or other sponsor of the device complies 
with the IDE regulations. If a PMA or notice of completion of a PDP is 
not filed by the latter of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of

[[Page 59133]]

section 510(f)(1)(A) of the act (21 U.S.C. 360(f)(1)(A)), and subject 
to seizure and condemnation under section 304 of the act (21 U.S.C. 
334), if its distribution continues. Shipment of devices in interstate 
commerce will be subject to injunction under section 302 of the act (21 
U.S.C. 332), and the individuals responsible for such shipment will be 
subject to prosecution under section 303 of the act (21 U.S.C. 333). In 
the past, FDA has requested that manufacturers take action to prevent 
the further use of devices for which no PMA has been filed and may 
determine that such a request is appropriate for the class III device 
that is the subject of this regulation.
    The act does not permit an extension of the 90-day period after 
issuance of a final rule within which an application or notice is 
required to be filed. The House Report on the 1976 amendments states 
that ``* * * the thirty month `grace period' afforded after 
classification of a device into class III * * * is sufficient time for 
manufacturers and importers to develop the data and conduct the 
investigations necessary to support an application of premarket 
approval'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    In the Federal Register of September 4, 1987 (47 FR 33686), FDA 
issued a final rule classifying the hip joint metal/polymer 
semiconstrained resurfacing cemented prosthesis into class III. 
Subsequently, FDA determined that the ceramic/polymer semiconstrained 
resurfacing cemented prosthesis was substantially equivalent to the 
metal/polymer semiconstrained resurfacing cemented prosthesis.
    In the Federal Register of March 5, 2004 (69 FR 10390), FDA issued 
a proposed rule to require the filing of a PMA or a notice of 
completion of a PDP for the hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis (the proposed rule). In 
accordance with section 515(b)(2)(A) of the act, FDA included in the 
preamble to the proposed rule the agency's proposed findings regarding 
the degree of risk of illness or injury intended to be eliminated or 
reduced by requiring the device to meet the statute's approval 
requirements as well as the benefits to the public from the use of the 
device.
    The March 5, 2004, proposed rule also provided an opportunity for 
interested persons to submit comments on the proposed rule and the 
agency's proposed findings. In accordance with section 515(b)(2)(A) of 
the act, FDA also provided an opportunity for interested persons to 
request a change in the classification of the device based on new 
information relevant to its classification. Interested persons 
requesting a change in the classification of the devices were to submit 
a petition by March 22, 2004. The comment period closed June 3, 2004.
    FDA received no petitions requesting a change in the classification 
of the hip joint metal/polymer or ceramic/polymer semiconstrained 
resurfacing cemented prosthesis. FDA received no comments on the 
proposed rule.

II. Device Subject to This Proposal

    A hip joint metal/polymer or ceramic/polymer semiconstrained 
resurfacing cemented prosthesis is a two-part device intended to be 
implanted to replace the articulating surfaces of the hip while 
preserving the femoral head and neck. 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 includes prostheses that consist of a femoral cap component made 
of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic 
material, that is placed over a surgically prepared femoral head, and 
an acetabular resurfacing polymer component. Both components are 
intended for use with bone cement.

III. Findings With Respect to Risks and Benefits

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the proposed rule of March 5, 2004. As required by section 
515(b) of the act, FDA published its findings regarding the following 
topics: (1) The degree of risk of illness or injury designed to be 
eliminated or reduced by requiring that these devices have an approved 
PMA or a declared completed PDP and (2) the benefits to the public from 
the use of the device.
    These findings are based on the reports and recommendations of the 
Orthopaedic Device Classification Panel, an FDA advisory committee, for 
the classification of the device, along with FDA's comprehensive review 
of the literature.

IV. The Final Rule

    Under section 515(b)(3) of the act, FDA adopts the findings as 
published in the preamble to the proposed rule and issues this final 
rule to require premarket approval for the hip joint metal/polymer or 
ceramic/polymer semiconstrained resurfacing cemented prosthesis. This 
final rule revises part 888 (21 CFR part 888).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before 90 days after the date of publication 
of this rule in the Federal Register (see DATES), for any hip joint 
metal/polymer or ceramic/polymer semiconstrained resurfacing cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has been found by FDA to be substantially equivalent to such a 
device on or before 90 days after the date of publication of this rule 
in the Federal Register. If a PMA or notice of completion of a PDP is 
filed for any such device within this time limit, the applicant will be 
permitted to continue marketing its hip joint metal/polymer or ceramic/
polymer semiconstrained resurfacing cemented prosthesis during FDA's 
review of its submission. Any other hip joint metal/polymer or ceramic/
polymer semiconstrained resurfacing cemented prosthesis that was not in 
commercial distribution before May 28, 1976, is required to have an 
approved PMA or a declared completed PDP in effect before it may be 
marketed.
    If a PMA or a notice of completion of a PDP for a hip joint metal/
polymer or ceramic/polymer semiconstrained resurfacing cemented 
prosthesis is not filed on or before 90 days after the date of 
publication of this rule in the Federal Register, that device is deemed 
adulterated under section 501(f)(1)(A) of the act (21 U.S.C. 
351(f)(1)(A)), and commercial distribution of the device must cease 
immediately. The device may, however, be distributed for 
investigational use, if the requirements of the IDE regulations (part 
812) are met. Because the hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis is intended to be used 
as an implant, FDA considers it to be a significant risk device as 
defined in the IDE regulation in Sec.  812.3(m)(1).
    The exemptions in Sec.  812.2(c)(1) and (c)(2) from the 
requirements of the IDE regulations for preamendments class III devices 
cease to apply to any hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis that is either: (1) Not 
legally on the market on or before 90 days after the date of 
publication of this rule in the Federal Register or (2) legally on the 
market but for which a PMA or notice of completion of a PDP is not 
filed within 90 days after the date of publication of this final rule 
in the Federal Register, or for which PMA approval has been denied or 
withdrawn. FDA cautions that manufacturers who are not immediately 
planning to submit a PMA or notice of completion of a PDP should submit 
IDE applications to FDA by 60 days after the date of publication of 
this final rule in the Federal Register,

[[Page 59134]]

to minimize the possibility of interrupting shipment of the device. At 
this time, FDA is not aware of any firm that is marketing this device.

V. PMA Requirements

    A PMA for these devices must include the information required by 
section 515(c)(1) of the act. Such a PMA should also include a detailed 
discussion of the risks identified previously, as well as a discussion 
of the effectiveness of the device for which premarket approval is 
sought. In addition, a PMA must include all data and information on the 
following topics: (1) Any risks known, or that should be reasonably 
known, to the applicant that have not been identified in this document; 
(2) the effectiveness of the device that is the subject of the 
application; and (3) full reports of all preclinical and clinical 
information from investigations on the safety and effectiveness of the 
device for which premarket approval is sought.

VI. PDP Requirements

    A PDP for any of these devices may be submitted in lieu of a PMA, 
and must follow the procedures outlined in section 515(f) of the act. A 
PDP should provide the following information: (1) A description of the 
device, (2) preclinical trial information (if any), (3) clinical trial 
information (if any), (4) a description of the manufacturing and 
processing of the devices, (5) labeling of the device, and (6) all 
other relevant information about the device. In addition, the PDP must 
include progress reports and records of the trials conducted under the 
protocol on the safety and effectiveness of the device for which the 
completed PDP is sought.
    Information about the PDP process is also available from the Center 
for Devices and Radiological Health on the Internet at http://www.fda.gov/cdrh/devadvice/pma/app_methods.html#product_dev.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

VIII. 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), 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 not a significant regulatory action 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 device has fallen out of use and FDA is 
not aware of any firm marketing the device, the agency has concluded 
that there is little or no interest in marketing this device in the 
future. The agency, therefore, certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $110 million. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA). The burden hours required 
for Sec.  888.3410(c), included in the collection entitled ``Premarket 
Approval of Medical Devices--21 CFR Part 814,'' are reported and 
approved under OMB control number 0910-0231. Therefore, clearance by 
OMB under the PRA is not required.

List of Subjects in 21 CFR Part 888

    Medical devices.

0
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

0
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.

0
2. Section 888.3410 is revised to read as follows:


Sec.  888.3410  Hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis.

    (a) Identification. A hip joint metal/polymer or ceramic/polymer 
semi-constrained resurfacing cemented prosthesis is a two-part device 
intended to be implanted to replace the articulating surfaces of the 
hip while preserving the femoral head and neck. 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 includes prostheses that consist of a femoral cap 
component made of a metal alloy, such as cobalt-chromium-molybdenum, or 
a ceramic material, that is placed over a surgically prepared femoral 
head, and an acetabular resurfacing polymer component. Both components 
are intended for use with bone cement (Sec.  888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before January 3, 2005, for any hip joint 
metal/polymer or ceramic/polymer semiconstrained resurfacing cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has, on or before January 3, 2005, been found to be substantially 
equivalent to a hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other hip joint metal/polymer or 
ceramic/polymer semiconstrained resurfacing cemented prosthesis must 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

    Dated: September 23, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22210 Filed 10-1-04; 8:45 am]
BILLING CODE 4160-01-S