[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