[Federal Register: April 28, 2005 (Volume 70, Number 81)]
[Rules and Regulations]
[Page 21947-21950]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap05-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 2002P-0520] (formerly Docket No. 02P-0520)
Dental Devices; Reclassification of Tricalcium Phosphate Granules
and Classification of Other Bone Grafting Material for Dental Bone
Repair
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying
tricalcium phosphate (TCP) granules for dental bone repair from class
III to class II (special controls), classifying into class II (special
controls) other bone grafting material for dental indications, and
revising the classification name and identification of the device type.
Bone grafting materials that contain a drug that is a therapeutic
biologic will remain in class III and continue to require a premarket
approval application. The classification identification includes
materials such as hydroxyapatite, tricalcium phosphate, polylactic and
polyglycolic acids, or collagen. This action is being taken to
establish sufficient regulatory controls that will provide reasonable
assurance of the safety and effectiveness of these devices. Elsewhere
in this issue of the Federal Register, FDA is announcing the
availability of the guidance document that will serve as the special
control for the class II devices.
EFFECTIVE DATE: May 31, 2005.
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:
michael.adjodha@fda.hhs.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
[[Page 21948]]
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 FDA, in response to a reclassification petition or on its
own initiative, has classified the device into class I or II.
II. Regulatory History of the Device
In the Federal Register of June 30, 2004 (69 FR 39377), FDA
proposed to reclassify TCP granules for dental bone repair from class
III to class II (special controls). Concurrently, FDA proposed to
classify into class II (special controls) all other bone grafting
material for dental indications, except those that contained a drug or
biologic component; and to revise the classification name and
identification of the device. In the proposed rule, FDA identified the
device type as bone grafting material such as hydroxyapatite,
tricalcium phosphate, demineralized bone additives, collagen, or
polylactic acid intended to fill, augment, or reconstruct periodontal
or bony defects of the oral and maxillofacial region.
The SUPPLEMENTARY INFORMATION section of the June 30, 2004,
proposed rule presented information on the classification
recommendations of the Dental Products Advisory Panel (the panel), a
summary of the reasons for the recommendations, a summary of the data
upon which the recommendations were based, and an assessment of the
device's risks to public health.
Also in the Federal Register of June 30, 2004 (69 FR 39485), FDA
announced the availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Dental Bone Grafting
Material'' that FDA intended to serve as the special control for TCP
and other bone grafting materials, if FDA classified and reclassified
this device type. FDA gave interested persons until September 28, 2004,
to comment on the proposed regulation and special controls draft
guidance document.
III. Analysis of the Comment and FDA's Response
FDA received one comment on the proposed rule and guidance
document. The comment said that TCP granules should remain in class III
(premarket approval) and that all other bone grafting materials for
dental indications should be regulated in class III because the
commenter believed the special controls (composition, physical
properties, and compliance with the American Society for Testing and
Materials (ASTM) composition standards) described in the draft guidance
document were not sufficient to provide a reasonable assurance of
safety and effectiveness for these devices. The comment states that
only evidence from clinical studies is sufficient to provide a
reasonable assurance of safety and effectiveness for these devices.
FDA disagrees in part with the comment. In most cases, FDA believes
that there is sufficient human experience with the dental bone grafting
material devices being reclassified and classified into class II to
establish a special controls guidance to provide reasonable assurance
of safety and effectiveness through the 510(k) process without the
submission of clinical data. FDA has determined that this experience
supports the conclusion that information on composition, physical
properties, and compliance with ASTM composition standards in a 510(k)
will provide adequate information for FDA review of the device, if
there is no change in the formulation, design, technology, or
indication for use of the device. In cases in which there is such a
change, however, the special controls guidance clearly states that FDA
recommends the submission of clinical data in the 510(k) to support a
substantial equivalence determination. If the manufacturer cannot
demonstrate that the new device is substantially equivalent, the device
will be found not substantially equivalent and a premarket approval
application may be required. This approach is consistent with the
general recommendations of the panel in 1995 and in 2003. Therefore,
FDA believes that special controls, in addition to general controls,
will provide a reasonable assurance of the safety and effectiveness of
these devices and these devices can be classified in class II. Bone
grafting material devices that contain a drug that is a therapeutic
biologic will remain in class III and continue to require a premarket
approval application.
IV. Summary of Final Rule
Therefore, under sections 513 and 520(l) of the act, FDA is
adopting the summary of reasons for the panel's recommendation, the
summary of data upon which the panel's recommendations are based, and
the assessment of the risks to public health stated in the proposed
rule published on June 30, 2004. Furthermore, FDA is issuing this final
rule, Sec. 872.3930 (21 CFR 872.3930), that reclassifies TCP granules
for dental bone repair from class III to class II (special controls);
classifies into class II (special controls) other bone grafting
material for dental indications; and revises the classification name
and identification of the device. Bone grafting materials that contain
a drug that is a therapeutic biologic will remain in class III and
continue to require a premarket approval application.
FDA is making the following changes to the identification of bone
grafting material:
Removing the phrase ``a naturally or synthetically
derived'' because it does not apply to all the examples that follow.
Removing ``demineralized bone additives.'' Minimally
manipulated demineralized bone is regulated as human cells, tissues,
and cellular and tissue-based products under section 361 of the Public
Health Service Act (21 CFR 1271.10). Human demineralized bone with
additives is regulated as a medical device and is subject to premarket
notification procedures. FDA intends to publish a separate rule for
human demineralized bone with additives to classify the device into
class II and establish a special control.
Adding ``polyglycolic'' to ``polylactic acids'' to more
clearly identify these materials as a class of poly(alpha-hydroxy)
acids because they are often supplied as a mixture.
Clarifying that bone grafting materials that contain a
drug that is a therapeutic biologic are the devices that will remain in
class III. Therapeutic biologics are biological response modifiers,
such as growth factors, cytokines, and certain monoclonal antibodies
that are regulated as drugs. Because insufficient information exists to
determine that general controls and special controls are sufficient to
provide a reasonable assurance of their safety and effectiveness, these
devices will remain in class III and continue to require premarket
approval applications.
FDA is also revising paragraph (c) in Sec. 872.3930 to clarify the
status of the devices described in paragraph (b)(2) that contain a drug
that is a therapeutic biologic. Devices that were not in commercial
distribution prior to May 28, 1976, generally referred to as
postamendments devices, are classified automatically by statute
(section 513(f) of the act (21 U.S.C. 360c(f)) into class III without
any FDA rulemaking process. Those devices remain in class III and
require a premarket approval application, unless and until the device
is reclassified into class I or II or FDA
[[Page 21949]]
issues an order finding the device to be substantially equivalent,
under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate
device that does not require premarket approval. The agency determines
whether new devices are substantially equivalent to predicate devices
by means of premarket notification procedures in section 510(k) of the
act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations. FDA has
previously found the devices described in paragraph (b)(2) to be
postamendments devices and not substantially equivalent to devices that
do not require premarket approval. Therefore, these devices are in
class III by operation of the statute and require premarket approval.
FDA has revised paragraph (c) to reflect this.
This action is being taken to establish sufficient regulatory
controls to provide reasonable assurance of the safety and
effectiveness of the devices in class II. The guidance document
entitled ``Class II Special Controls Guidance Document: Dental Bone
Grafting Material Devices'' will serve as the special control for the
device. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of this guidance. Following the effective
date of the final rule, any firm submitting a 510(k) premarket
notification for this device will need to address the issues covered in
the special controls guidance document. 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.
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: Material 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 exempting 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.
V. Environmental Impact
FDA has determined under 21 CFR 25.34(b) that this classification
and reclassification action 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.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, 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. FDA believes that manufacturers of the devices being
reclassified or classified into class II are already substantially in
compliance with the recommendations in the guidance document. Because
manufacturers of the devices subject to the special control are being
relieved of the burden of submitting a premarket approval application,
the agency 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 $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. Federalism
FDA has analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies conferring 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, FDA has concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive order. As a result, a federalism summary
impact statement is not required.
VIII. Paperwork Reduction Act of 1995
FDA concludes that the final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget, according to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520) is not required.
List of Subjects in 21 CFR Part 872
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
872 is amended as follows:
PART 872--DENTAL DEVICES
0
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.
0
2. Section 872.3930 is revised to read as follows:
Sec. 872.3930 Bone grafting material.
(a) Identification. Bone grafting material is a material such as
hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic
acids, or collagen, 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) for bone
grafting materials that do not contain a drug that is a therapeutic
biologic. The special control is FDA's ``Class II Special Controls
Guidance Document: Dental Bone Grafting Material Devices.'' (See Sec.
872.1(e) for the availability of this guidance document.)
(2) Class III (premarket approval) for bone grafting materials that
contain a drug that is a therapeutic biologic. Bone grafting materials
that contain a drug that is a therapeutic biologic, such as biological
response modifiers, require premarket approval.
(c) Date premarket approval application (PMA) or notice of product
development protocol (PDP) is required. Devices described in paragraph
(b)(2) of
[[Page 21950]]
this section shall have an approved PMA or a declared completed PDP in
effect before being placed in commercial distribution.
Dated: April 4, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-8467 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S