[Federal Register: June 30, 2004 (Volume 69, Number 125)]
[Proposed Rules]
[Page 39377-39380]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn04-12]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 2002P-0520]
Dental Devices; Tricalcium Phosphate Granules and Other Bone
Grafting Material for Dental Bone Repair
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify tricalcium phosphate (TCP) granules for dental bone repair
from class III to class II (special controls); classify into class II
(special controls) all other bone grafting material for dental
indications, except those that contain drug or biologic components; and
revise the classification name and identification of the device. Bone
grafting materials that contain a drug or biologic component would
remain in class III. The proposed classification identification
includes materials such as hydroxyapatite, demineralized bone
additives, collagen, and polylactic acids. After considering public
comments on the proposed reclassification and classification, FDA will
publish a final regulation, if appropriate. This action is being taken
to establish sufficient regulatory controls that will provide
reasonable assurance of the safety and effectiveness of this device.
Elsewhere in this issue of the Federal Register, FDA is publishing a
notice of availability of a draft guidance document that the agency
proposes to use as a special control for the device.
DATES: Submit written or electronic comments by September 28, 2004. See
section VI of this document for the proposed effective date of a final
rule based on this document.
ADDRESSES: You may submit comments, identified by Docket No. 2002P-
0520, by any of the following methods:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations. gov.
Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2002P-
0520 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850; 301-827-5283; e-mail:
mea@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
(Public Law 101-629), the Food and Drug Administration Modernization
Act of 1997 (Public Law 105-115), and the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250) 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 the following requirements are met: (1) FDA has
received a recommendation from a device classification panel (an FDA
advisory committee); (2) FDA has published the panel's recommendation
for comment, along with a proposed regulation classifying the device;
and (3) FDA has published a final regulation classifying the device.
FDA has classified most preamendments devices under these procedures.
Under section 520(l) of the act (21 U.S.C. 360j(l)), devices
formerly regulated as new drugs are automatically classified into class
III, unless the Secretary of Health and Human Services, in response to
a reclassification petition, has classified the device into class I or
II.
II. Recommendation of the Panel
A. Identification of the Device
In the Federal Register of August 12, 1987 (52 FR 30082), FDA
issued a final rule codifying the classification of ``tricalcium
phosphate for dental bone repair'' as a class III device under the 1976
amendments. At that time, FDA was not aware that bone grafting
material, other than TCP, was a preamendments device and inadvertently
omitted classifying it. Consistent with the act and regulations, FDA
has since consulted with the Dental Products Advisory Panel (the
panel), an FDA advisory committee, regarding classification of this
device.
On November 12, 2002, Bicon, Inc., Boston, MA, submitted a petition
to FDA to reclassify beta-tricalcium phosphate for dental indications
from ``Class III to Class Unclassified'' (Ref. 1). On December 9, 2002,
the petitioner amended its petition to make clear that it was
requesting that FDA reclassify beta-tricalcium phosphate from class III
to class II. Beta-tricalcium phosphate and all other forms of
tricalcium phosphate for dental bone repair, including alpha and
amorphous forms, are transitional devices and are currently regulated
as class III devices under 21 CFR 872.3930, ``Tricalcium phosphate
granules for dental bone
[[Page 39378]]
repair,'' requiring premarket approval. Consistent with section
520(l)(2) the act and the regulations in 21 CFR 860.136, FDA consulted
with the panel regarding reclassification of this device.
Other bone grafting materials in the form of synthetic hard tissue
replacements have been used in dentistry since the 1970s (Ref. 2).
Because they were inadvertently omitted from the August 12, 1987, final
rule classifying most dental devices, these other bone grafting
materials are unclassified preamendments devices. Although
unclassified, they are nevertheless subject to general controls, such
as premarket notification. TCP and other bone grafting materials share
the same indications, risks, and recommended mitigation measures.
FDA believes that one classification identification that
encompasses all bone grafting materials for dental indications would
provide a more scientifically accurate and more administratively
transparent regulation for these materials. Therefore, FDA is
identifying bone grafting material as a naturally or synthetically
derived material, such as hydroxyapatite, tricalcium phosphate,
demineralized bone additives, collagen, or polylactic acids, that is
intended to fill, augment, or reconstruct periodontal or bony defects
of the oral and maxillofacial region.
B. Recommended Classification of the Panel
At the meeting of the Dental Products Advisory Panel held on May
22, 2003, the panel voted five to zero (with no abstentions) to
recommend that TCP for dental indications be reclassified from class
III to class II (special controls). The panel considered all forms of
TCP, including beta-tricalcium phosphate, and concluded that special
controls, in addition to general controls, would provide reasonable
assurance of the safety and effectiveness of these bone grafting
materials devices (Ref. 3).
In addition, on August 8 and 9, 1995, in accordance with the
procedures set forth in 21 CFR 860.84, the panel considered
classification of the non-TCP materials. The panel recommended
unanimously that non-TCP bone grafting materials be classified into
class II, except when intended to be used alone in filling or repair of
bony defects and/or augmentation of the alveolar ridge. For that
indication, the panel recommended placing the device in class III, but
with a low priority for establishing an effective date for the
requirement for premarket approval (Ref. 4).
C. Summary of Reasons for the Recommendation
For TCP for dental indications and for bone grafting materials for
certain dental indications, the panel believed that special controls,
in addition to general controls, would provide reasonable assurance of
the safety and effectiveness of these devices and that there is
sufficient information to establish special controls to provide such
assurance.
The panel recommended that TCP should remain in class III when used
alone in filling or repair of bony defects and/or augmentation of the
alveolar ridge because they believed that the materials present risks
to health that cannot be addressed by special controls.
D. Summary of the Data for the Recommendation
For TCP for dental indications, the panel based its recommendation
on the information provided by the petitioner and FDA, the
presentations made by stakeholders and FDA at the panel meeting, the
open discussion during the panel meeting, and the panel members'
personal knowledge of and clinical experience with the device (Ref. 5).
The panel did not discuss bone grafting materials containing a drug or
biologic component.
For non-TCP materials, the panel based its recommendation on the
information provided by FDA, presentations made by stakeholders who
marketed bone filling and augmentation devices, the open discussion
during the panel meeting, and the panel members' personal knowledge of
and clinical experience with the device.
III. Risks to Health
The panel identified the following risks to health associated with
bone grafting material: Ineffective bone formation, adverse tissue
reaction, infection, and improper use.
A. Ineffective Bone Formation
The quality and physical properties of bone grafting material may
be insufficient to support the required loads and lead to device
failure. Device failure may result in ineffective treatment, revision,
and permanent impairment for the patient.
B. Adverse Tissue Reaction
Inadequate biocompatibility of any of the components contained in
bone grafting material may result in adverse tissue reaction and
presents the potential for surgical revision (i.e., reoperation).
C. Infection
Implantation of an improperly sterilized device may result in an
infection. Infection may result in revision or explantation of the
device, which presents the potential for permanent impairment.
D. Improper Use
Inadequate labeling may result in improper use. Improper use may
result in ineffective treatment and may cause permanent impairment.
IV. Proposed Rule
FDA believes that bone grafting material that does not contain a
drug or biologic component should be classified into class II and that
TCP should be reclassified 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 to provide such assurance.
FDA disagrees with the (1995) panel's recommendation that bone
grafting materials should remain in class III when used alone in
filling or repair of bony defects and/or augmentation of the alveolar
ridge. FDA believes that when used for these indications, the risks to
health can be addressed by special controls and that all of these bone
grafting material devices share the same risks and recommended
mitigation measures. Accordingly, FDA has developed the draft guidance
document entitled ``Class II Special Controls Guidance Document: Dental
Bone Grafting Material'' to serve as the special control for TCP and
other bone grafting material devices for dental indications. As noted
previously, bone grafting material that contains a drug or biologic
component would remain in class III and the special control guidance
document would not apply.
V. Proposed Special Control
FDA believes that the special controls guidance document entitled
``Class II Special Controls Guidance Document: Dental Bone Grafting
Material,'' in addition to general controls, can address the risks to
health described in section III of this document. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of
the draft guidance document.
If adopted, following the effective date of a final rule
reclassifying and classifying the device, any firm submitting a 510(k)
premarket notification for the device would need to address the issues
covered in the special control guidance. However, the firm would need
to show only that its
[[Page 39379]]
device meets the recommendations of the guidance or in some other way
provides equivalent assurances of safety and effectiveness.
The special controls guidance document contains recommendations
with regard to the information and testing that should be included in a
premarket notification. The guidance document addresses the following
topics: Characterization, biocompatibility, sterilization, and
labeling. Adequate characterization of the composition, physical
properties, and in vivo performance can address the risk of ineffective
bone formation. Adequate biocompatibility can address the risk of
adverse tissue reaction. Sterilization can address the risk of
infection, and labeling can address the risk of improper use.
The agency is not proposing to exempt this device from the
premarket notification requirements of the act, as permitted by section
510(m) of the act (21 U.S.C. 360(m)). FDA believes that it needs to
review information in a premarket notification submission that
addresses the risks identified in the guidance document in order to
assure that a new device is at least as safe and effective as legally
marketed devices of this type.
VI. Effective Date
FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
VII. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
classification is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, as
categorically excluded, neither an environmental assessment nor an
environmental impact statement is required.
VIII. Analysis of Impacts
FDA has examined the impacts of the proposed 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 proposed rule is not a significant regulatory action as defined by
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. Manufacturers of the preamendments devices that FDA
is reclassifying are being relieved of the burden of eventually
submitting a premarket approval application. Manufacturers of these
devices are already subject to the premarket notification requirements.
FDA has designated a guidance document as the special control. FDA
believes that manufacturers, including small manufacturers, are already
substantially in compliance with the recommendations in the guidance
document, and they will not need to submit substantially more
information in their premarket notification submissions in order to
meet the recommendations in the guidance document or otherwise provide
reasonable assurances of safety and effectiveness. FDA believes that
any regulation based on this proposed rule will impose no significant
economic impact on any small entities. The agency, therefore, certifies
that this proposed rule will not have a significant impact on a
substantial number of small entities. In addition, it 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 or analysis under section 202(a) of the Unfunded
Mandates Reform Act of 1995 is not required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) is not required.
X. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
XI. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Bicon, Inc., Boston, MA to FDA, November 12,
2002.
2. Le Geros, R. Z., ``Calcium Phosphate Materials in Restorative
Dentistry: A Review,'' Advances in Dental Research, vol. 2, pp. 164-
180, 1988.
3. Dental Products Panel of the Medical Devices Advisory
Committee, meeting transcript, May 22, 2003.
4. Dental Products Panel of the Medical Devices Advisory
Committee, meeting transcript, August 8 and 9, 1995.
5. Dental Products Panel of the Medical Devices Advisory
Committee, information package, May 22, 2003.
List of Subjects in 21 CFR Part 872
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 872 be amended in subpart D as follows:
PART 872--DENTAL DEVICES
1. The authority citation for 21 CFR Part 872 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 872.3930 is revised to read as follows:
Sec. 872.3930 Bone grafting material.
(a) Identification. Bone grafting material is a naturally or
synthetically derived material, such as hydroxyapatite, tricalcium
phosphate, demineralized bone additives, collagen, or polylactic acids,
that is intended to fill, augment, or reconstruct periodontal or bony
defects of the oral and maxillofacial region.
(b) Classification. (1) Class II (special controls) if it contains
no drug or biologic component. The special control for bone grafting
materials that do not contain a drug or biologic component is FDA's
``Class II Special Controls Guidance Document: Dental Bone Grafting
Material.'' (See Sec. 872.1(e) for the availability of this guidance
document.)
(2) Class III (premarket approval) if it contains a drug or
biologic component. Bone grafting materials that contain a drug or
biologic component, such as biological response modifiers, require
premarket approval.
(c) Date PMA or notice of PDP is required. For devices described in
paragraph (b)(2) of this section, no
[[Page 39380]]
effective date has been established for the requirement of premarket
approval. (See Sec. 872.3).
Dated: May 4, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-14767 Filed 6-29-04; 8:45 am]
BILLING CODE 4160-01-S