[Federal Register: June 2, 2003 (Volume 68, Number 105)]
[Rules and Regulations]
[Page 32635-32637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn03-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 01N-0411]
Orthopedic Devices; Classification for the Resorbable Calcium
Salt Bone Void Filler Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
resorbable calcium salt bone void filler device intended to fill bony
voids or gaps of the extremities, spine, and pelvis that are caused by
trauma or surgery and are not intrinsic to the stability of the bony
structure into class II (special controls). Elsewhere in this issue of
the Federal Register, FDA is announcing the availability of a class II
special controls guidance entitled ``Class II Special Controls Guidance
Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for
Industry and FDA.'' This action is being undertaken based on new
information submitted in a classification proposal from Wright Medical
Technology under the Federal Food, Drug, and Cosmetic Act as amended by
the Medical Device Amendments of 1976, the Safe Medical Devices Act of
1990, and the Food and Drug Administration Modernization Act of 1997.
Dates: This rule is effective July 2, 2003
FOR FURTHER INFORMATION CONTACT: Nadine Y. Sloan, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
[[Page 32636]]
Corporate Blvd., Rockville, MD 20850, 301-594-1296.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 7, 2002 (67 FR 5753), FDA
issued a proposed rule to classify the resorbable calcium salt bone
void filler device into class II based on new information regarding
this device and on the recommendation of the Orthopedic and
Rehabilitation Devices Panel. FDA identified the draft guidance
document entitled ``Class II Special Controls Guidance Document:
Resorbable Calcium Salt Bone Void Filler Device; Draft Guidance for
Industry and FDA'' as the proposed special control capable of providing
reasonable assurance of the safety and effectiveness of the device. The
device is intended to fill bony voids or gaps of the extremities,
spine, and pelvis that are caused by trauma or surgery and are not
intrinsic to the stability of the bony structure. FDA invited
interested persons to comment on the proposed rule by May 8, 2002. FDA
received two comments, both supporting the proposed classification. One
of the two comments also requested minor changes to the class II
special controls guidance document.
II. Analysis of Comments and FDA's Response
One comment expressed concern over a perceived intent to apply the
guidance to demineralized bone matrix (DBM) products. FDA acknowledges
that there was a misunderstanding about whether the proposed rule
applied to DBM products that have the same intended use as the
resorbable calcium salt bone void filler device and that were recently
determined to be medical devices. The proposed rule was intended to be
specific to the resorbable calcium salt bone void filler device,
including resorbable calcium salt bone void fillers that may contain
some biologically sourced additives, including DBM. The proposed rule
was not intended to apply to DBM products, i.e., products that contain
DBM without any calcium salt or that are composed primarily of DBM. For
clarity, FDA has deleted reference to all biologically sourced
materials included in the proposed rule and draft class II special
controls guidance and will address devices made of these other
materials in the future.
III. FDA's Conclusion
Based on a review of the available information in the preamble to
the proposed rule and placed on file in FDA's Dockets Management
Branch, FDA concludes that special controls, in conjunction with
general controls, provide reasonable assurance of the safety and
effectiveness of this device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the class II special
controls guidance document. The class II special controls guidance
document was revised to reflect consideration of the comments received.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a resorbable
calcium salt bone void filler device will need to address the issues
covered in the class II 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.
FDA is now codifying the classification and the class II special
control guidance document for the resorbable calcium salt bone void
filler device by adding Sec. 888.3045. For the convenience of the
reader, FDA is also adding Sec. 888.1(e) to inform the reader where to
find guidance documents referenced in 21 CFR part 888.
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), 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 it 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. These devices are already subject to general
controls, such as premarket notification. The class II special controls
guidance document will not substantially change the way in which these
devices are regulated. The agency, therefore, certifies that the final
rule will not have a significant 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 State, local, and
tribal governments in the aggregate and, therefore, a summary statement
of analysis under section 202(a) of the Unfunded Mandates Reform Act 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 Executive order and, consequently, a
federalism summary impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule does not contain information collection provisions
that are subject to review by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
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 888.3045 is added to subpart D to read as follows:
Sec. 888.3045 Resorbable calcium salt bone void filler device.
(a) Identification. A resorbable calcium salt bone void filler
device is a resorbable implant intended to fill bony voids or gaps of
the extremities, spine, and pelvis that are caused by trauma or
[[Page 32637]]
surgery and are not intrinsic to the stability of the bony structure.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler
Device; Guidance for Industry and FDA.'' See Sec. 888.1(e) of this
chapter for the availability of this guidance.
Dated: April 9, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-13592 Filed 5-30-03; 8:45 am]
BILLING CODE 4160-01-S