[Federal Register Volume 68, Number 105 (Monday, June 2, 2003)]
[Rules and Regulations]
[Pages 32635-32637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13592]


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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 FDA identified the draft guidance 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Resorbable Calcium Salt Bone Void Filler Device; Draft Guidance for 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