[Federal Register Volume 60, Number 229 (Wednesday, November 29, 1995)]
[Proposed Rules]
[Pages 61232-61237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29083]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food And Drug Administration
21 CFR Part 872
[Docket No. 95N-0298]
Dental Devices; Effective Date of Requirement for Premarket
Approval of Partially Fabricated Denture Kits
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; opportunity to request a change in
classification.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for partially
fabricated denture kits. The agency is also summarizing its proposed
findings regarding the benefits to the public from use of the device as
well as the degree of risk of illness or injury intended to be
eliminated or reduced by requiring that the device have an approved PMA
or a completed PDP. In addition, FDA is announcing an opportunity for
interested persons to request the agency to change the classification
of the device based on new information.
DATES: Written comments by February 27, 1996; requests for a change in
classification by December 14, 1995. FDA intends that if a final rule
based on this proposal is issued, PMA's or notices of completion of
PDP's will be required to be submitted within 90 days of the effective
date of the final rule.
ADDRESSES: Submit written comments or requests for a change in
classification to the Dockets Management Branch (HFA-305), Food and
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Louis Hlavinka, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8879.
SUPPLEMENTARY INFORMATION:
I. Background
Section 513 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360c) requires the classification of medical devices into
one of three regulatory classes: Class I (general controls), class II
(special controls), and class III (premarket approval). Generally,
devices that were on the market before May 28, 1976, the date of
enactment of the Medical Device Amendments of 1976 (the amendments)
(Pub. L. 94-295), and devices marketed on or after that date that are
substantially equivalent to such devices, have been classified by FDA.
For the sake of convenience, this preamble refers to the devices that
were on the market on or after that date as ``preamendments devices.''
Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes 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
notice of completion of a PDP until 90 days after FDA promulgates 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, such a device is exempt from the
investigational device exemption (IDE) requirements (part 812 (21 CFR
part 812)) until the date stipulated by FDA in the final rule requiring
the submission of a PMA application or a notice of completion of a PDP
for that device. At that time, an IDE must be submitted only if a PMA
has not been submitted or a PDP not completed.
Section 515(b)(2)(A) of the act provides that a proceeding to issue
a final rule to require premarket approval
[[Page 61233]]
shall be initiated by publication of a notice of proposed rulemaking
containing: (1) The proposed rule, (2) proposed findings with respect
to the degree of risk of illness or injury designed to be eliminated or
reduced by requiring the device to have an approved PMA or a declared
completed PDP and the benefit to the public from the use of the device,
(3) an opportunity for the submission of comments on the proposed rule
and the proposed findings, and (4) an opportunity to request a change
in the classification of the device based on new information relevant
to the classification of the device.
Section 515(b)(2)(B) of the act provides that if FDA receives a
request for a change in the classification of the device within 15 days
of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change of
classification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the act. If FDA does not
initiate such a proceeding, section 515(b)(3) of the act provides that
FDA shall, after the close of the comment period on the proposed rule
and consideration of any comments received, promulgate a final rule to
require premarket approval, or publish a notice terminating the
proceeding. If FDA terminates the proceeding, FDA is required to
initiate reclassification of the device under section 513(e) of the
act, unless the reason for termination is that the device is a banned
device under section 516 of the act (21 U.S.C. 360f).
If a proposed rule to require premarket approval for a
preamendments device is made final, section 501(f)(2)(B) of the act (21
U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a
PDP for any such device be filed within 90 days of the date of
promulgation of the final rule or 30 months after final classification
of the device under section 513 of the act, whichever is later. If a
PMA or a notice of completion of a PDP is not filed by the later of the
two dates, commercial distribution of the device is required to 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 a notice of completion of a PDP is not
filed by the later of the two dates, and no IDE is in effect, the
device is deemed to be adulterated, within the meaning of section
501(f)(1)(A) of the act, and subject to seizure and condemnation under
section 304 of the act (21 U.S.C. 334) if its distribution continues.
Shipment of the device 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 or notice of completion of a PDP has
been filed and may determine that such a request is appropriate for
partially fabricated denture kits.
The act does not permit an extension of the 90-day period after
promulgation of a final rule within which an application or a notice is
required to be filed. The House report (H. Rept.) on the 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 for premarket
approval.'' (H. Rept. 94-853 Cong., 2d sess. 42 (1976)).
A. Classification of Partially Fabricated Denture Kits
In the Federal Register of August 12, 1987 (52 FR 30082), FDA
issued a final rule classifying partially fabricated denture repair
kits into class III. The preamble to the proposal to classify the
device published in the Federal Register of December 30, 1980 (45 FR
85962), included the recommendation of the Dental Devices
Classification Panel (the Panel), an FDA advisory committee, regarding
the classification of the devices. The Panel recommended that partially
fabricated denture kits be in class III (premarket approval). The Panel
believed that general controls and performance standards would not
provide reasonable assurance of the safety and effectiveness of these
devices and that there was insufficient information to establish such
standards.
In the Federal Register of January 6, 1989 (54 FR 550), FDA
published a notice of intent to initiate proceedings to require
premarket approval for 31 class III preamendments devices. Among other
items, the notice described the factors FDA takes into account in
establishing priorities for proceedings under section 515(b) of the act
for promulgating final rules requiring that preamendments class III
devices have approved PMA's or declared completed PDP's. Partially
fabricated denture kits were not included in the list of devices
identified in that notice. FDA updated its priorities in a
preamendments class III strategy document made public through a Federal
Register notice of availability published on May 6, 1994 (59 FR 23731).
Accordingly, FDA has recently determined that partially fabricated
denture kits identified in 21 CFR 872.3600 have a high priority for
initiating a proceeding to require premarket approval because the
safety and effectiveness of the device has not been established by
valid scientific evidence as defined in Sec. 860.7 (21 CFR 860.7).
Accordingly, FDA is commencing a proceeding under section 515(b) of the
act to require that the partially fabricated denture kit have an
approved PMA or declared completed PDP.
B. Dates New Requirements Apply
In accordance with section 515(b) of the act, FDA is proposing to
require that a PMA or a notice of completion of a PDP be filed with the
agency for the partially fabricated denture kit within 90 days after
promulgation of any final rule based on this proposal. An applicant
whose device was legally in commercial distribution before May 28,
1976, or whose device has been found by FDA to be substantially
equivalent to such a device, will be permitted to continue marketing
the partially fabricated denture kit during FDA's review of the PMA or
notice of completion of the PDP. FDA intends to review any PMA for the
device within 180 days, and any notice of completion of a PDP for the
device within 90 days of the date of filing. FDA cautions that, under
section 515(d)(1)(B)(i) of the act, FDA may not enter into an agreement
to extend the review period of a PMA beyond 180 days unless the agency
finds that ``* * * the continued availability of the device is
necessary for the public health.''
FDA intends that, under Sec. 812.2(d), the preamble to any final
rule based on this proposal will state that, as of the date on which a
PMA or a notice of completion of a PDP is required to be filed, the
exemptions in Sec. 812.2(c)(1) and (c)(2) from the requirements of the
IDE regulations for preamendments class III devices will cease to apply
to any partially fabricated denture kit which is: (1) Not legally on
the market on or before that date, or (2) legally on the market on or
before that date but for which a PMA or notice of completion of a PDP
is not filed by that date, or for which a PMA approval has been denied
or withdrawn.
If a PMA or a notice of completion of a PDP for the partially
fabricated denture kit is not filed with FDA within 90 days after the
date of issuance of any final rule requiring premarket approval for the
devices, commercial distribution
[[Page 61234]]
of the device must cease. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. An approved IDE is required to be in effect before an
investigation of the device may be initiated or continued. FDA,
therefore, cautions that, for manufacturers not planning to submit a
PMA immediately, an IDE application should be submitted to FDA at least
30 days before the end of the 90 day period after the final rule is
published in the Federal Register to minimize the possibility of
interrupting all availability of the device. FDA does not consider an
investigation of the partially fabricated denture kit to pose a
significant risk as defined in the IDE regulation. The device may be
distributed for investigational use if manufacturers, importers, or
other sponsors comply with the abbreviated requirements (Sec. 812.1(b))
of the IDE regulation.
C. Description of Device
A partially fabricated denture kit is a device composed of
connected preformed teeth that is intended for use in construction of a
denture. A denture base is constructed using the patient's mouth as a
mold, by partially polymerizing the resin denture base materials while
the materials are in contact with the oral tissues. After the denture
base is constructed, the connected preformed teeth are chemically
bonded to the base.
D. Proposed Findings With Respect to Risks and Benefits
As required by section 515(b) of the act, FDA is publishing its
proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring partially
fabricated denture kits to have an approved PMA or a declared completed
PDP, and (2) the benefits to the public from the use of the device.
E. Risk Factors
Partially fabricated denture kits have been associated with
potential risks relative to jaw relationships, adverse tissue reaction,
and materials composition.
The risks associated with jaw relationships are: (1) Inaccurate
vertical dimension of occlusion; (2) improper occlusal plane and tooth
ridge relationships; (3) jaw joint dysfunction and esthetic problems
caused by inaccurate reproduction of the physiologic dimensions of the
mandible; and (4) unsatisfactory centric and eccentric relations to
ensure proper distribution of pressure to the edentulous-bearing areas.
The risks related to adverse tissue reaction include: (1)
Irritation of the oral cavity soft tissues; (2) monilial infection; (3)
unusual hard and soft tissue changes; (4) tissue health maintenance
difficulties; and (5) allergy or sensitization caused by the leaching
of unreacted resin monomer on initial fitting or insertion of the
denture.
The risks relative to materials composition: (1) Deterioration of
the acrylic plastic denture base over time; (2) unsatisfactory
performance of the denture materials; and (3) ill-fitting dentures
resulting from decomposition or distortion of the acrylic plastic
caused by improper finishing techniques and jeopardy to the patient's
oral health resulting from the use of dentures fabricated by dental
office techniques that bypass traditionally controlled, accepted, and
proven laboratory procedures (Refs. 1 through 10).
F. Benefits of the Device
A partially fabricated denture kit is constructed by chemically
bonding preformed teeth to a common base. The patient's mouth is used
as a mold by partially polymerizing the resin denture base while the
materials are in contact with oral tissues. The potential benefits
intended from the use of a partially fabricated denture kit are:
potential modification of the size and shape of the prefabricated
denture to the specific oral configuration and relationships for some
patients; a reduction in the amount of time needed by the practitioner
and auxiliary staff to fabricate a denture for the patient; fewer
laboratory procedures compared with conventional methods of denture
construction outside the dental office; reduction of commercial
laboratory charges and potential reduction of denture costs to the
patient; and availability of a denture intended for temporary use.
(Refs. 1, 3 through 5, 8, and 10).
G. Need for Information for Risk/Benefit Assessment of the Device
FDA classified the partially fabricated denture kit into class III
because it determined that insufficient information existed to
determine that general controls would provide reasonable assurance of
the safety and effectiveness of the device or to establish a
performance standard to provide such assurance. FDA has determined that
the special controls that may now be applied to class II devices under
the Safe Medical Devices Act of 1990 also would not provide such
assurance. FDA has weighed the probable risks and benefits to the
public health from the use of the device and believes that the
literature reports and other information discussed above suggest the
potential for unreasonable risks associated with the use of the device.
These risks must be addressed by the manufacturers of partially
fabricated denture kits. FDA believes that partially fabricated denture
kits should undergo premarket approval to establish effectiveness and
to determine whether the benefits to the patient are sufficient to
outweigh any risk.
II. PMA Requirements
A PMA for this device must include the information required by
section 515(c)(1) of the act and Sec. 814.20 (21 CFR 814.20) of the
procedural regulations for PMA's. Such a PMA should include a detailed
discussion of the risks identified above, 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: (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
specific partially fabricated denture kit 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.
A PMA should include valid scientific evidence as defined in
Sec. 860.7 and should be obtained from well-controlled clinical
studies, with detailed data, in order to provide reasonable assurance
of the safety and effectiveness of the partially fabricated denture kit
for its intended use. In addition to the basic requirements described
in Sec. 814.20(b)(6)(ii) for a PMA, it is recommended that such studies
employ a protocol that meets the criteria described below.
Applicants should submit any PMA in accordance with FDA's guideline
entitled ``Guideline for the Arrangement and Content of a PMA
Application.'' The guideline is available upon request from FDA, Center
for Devices and Radiological Health, Division of Small Manufacturers
Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850.
A. -General Protocol Requirements
The partially fabricated denture kit should be evaluated in a
prospective, randomized, controlled clinical trial that uses adequate
controls. The study must attempt to answer all of the general and
specific questions about the safety and effectiveness of the devices,
including the risk to benefit ratio. These questions should relate to
the pathophysiologic effects which the
[[Page 61235]]
device produces, as well as the primary and secondary variables
analyzed to evaluate safety and effectiveness. Study endpoints and
study success must be defined.
Animal toxicity studies should be conducted according to the
International Standard ISO-10993, ``Biological Evaluation of Medical
Devices Part-1: Evaluation and Testing.'' Specifically:
(1) The selection of material(s) to be used in device manufacture
and its toxicological evaluation should initially take into account
full characterization of the material, for example, formulation, known
and suspected impurities, and processing.
(2) The material(s) of manufacture, the final product and possible
leachable chemicals or degradation products should be considered for
their relevance to the overall toxicological evaluation of the device.
(3) Any in vitro or in vivo experiments or tests must be conducted
according to recognized good laboratory practices followed by an
evaluation by competent informed persons.
(4) Any change in chemical composition, manufacturing process,
physical configuration or intended use of the device must be evaluated
with respect to possible changes in toxicological effects and the need
for additional testing.
(5) The toxicological evaluation performed in accordance with the
guidance should be considered in conjunction with other information
from other nonclinical studies and postmarket experiences for an
overall safety assessment.
Examples of questions to be addressed by the clinical studies may
include the following:
1. What morbidity (irritation of the oral cavity soft tissues,
monilial infection, unusual hard and soft tissue changes,
sensitization, or allergic response) is associated with the subject
device in the patient population and how does this compare to the
control?
2. What impact does the device have on the vertical dimension of
the occlusion?
3. What are the long term effects of the device on the oral tissue?
4. What changes in physical characteristics (hardness, dimensional
stability, etc.) of the materials take place over time?
5. Does the device provide a functional level of retention for the
user?
6. Does the device allow sufficient comfort for the user?
7. Does the partially fabricated denture provide adequate strength
for the denture to function properly?
8. What criteria are used to select the correct size of partially
fabricated denture for an individual patient?
9. Because the teeth are preset, how is the individual occlusal
plane determined to avoid traumatic occlusion?
10. Does the device allow the patient to be able to masticate food,
insofar as oral and psychologic conditions will permit?
11. Does use of the device result in the patient presenting a
normal individual appearance that satisfies esthetic requirements?
Statistically valid investigations should include a clear statement
of the objectives of the study. Appropriate rationale, supported by
background literature on previous uses of the device and proposed
mechanisms for its effect, should be presented as justification for the
questions to be answered, and the definitions of study endpoints and
success. Clear study hypotheses should be formulated based on this
information.
B. Study Sample Requirements
The subject population should be well defined. Ideally, the study
population should be as homogeneous as possible in order to minimize
selection bias and reduce variability. Otherwise, an unusually large
population may be necessary to achieve statistical significance.
Independent studies producing comparable results at multiple study
sites using identical protocols are necessary to demonstrate
repeatability. Justification must be provided for the sample size used
to show that a sufficient number of completely edentulous patients were
enrolled to attain statistically and clinically meaningful results.
Eligibility criteria for the subject population should include the
subject's potential for benefit, the ability to detect a benefit in the
subject, the absence of both contraindications and any competing risk
and assurance of subject compliance. In a heterogeneous sample,
stratification of the patient groups participating in the clinical
study may be necessary to analyze homogeneous subgroups and thereby
minimize potential bias. All endpoint variables should be identified,
and a sufficient number of patients from each subgroup analysis should
be included to allow for stratification by pertinent demographic
characteristics.
The investigation should include an evaluation of comparability
between treatment groups and control groups (including historical
controls). Baseline (e.g., age, gender, etc.) and other variables
should be measured and compared between the treatment and control
groups. The baseline variables should be measured at the time of
treatment assignment, not during the course of the study. Other
variables should be measured during the study as needed to completely
characterize the device's safety and effectiveness.
C.- Study Design
All potential sources of error, including selection bias,
information bias, misclassification bias, comparison bias, or other
potential bias should be evaluated and minimized. The study should
clearly measure any possible placebo effect. Treatment effects should
be based on objective measurements. The validity of these measurement
scales should be shown to ensure that the treatment effect being
measured reflects the intended uses of the device.
Adherence to the protocol by subjects, investigators, and all other
individuals involved is essential and requires monitoring to assure
compliance by both patients and physicians. Subject exclusion due to
dropout or loss to followup greater than 20 percent may invalidate the
study due to bias potential; therefore, initial patient screening and
compliance of the final subject population will be needed to minimize
the dropout rate. All dropout must be accounted for and the
circumstances and procedures used to ensure patient compliance must be
well documented.
Endpoint assessment cannot be based solely on a statistical value.
Instead, the clinical outcome must be carefully defined to distinguish
between the evaluation of the proper function of the device versus its
benefit to the subject. Statistical significance and effectiveness of
the device must be demonstrated by the statistical results. However,
under certain restricted circumstances, a clinically significant result
may be acceptable without statistical significance.
Observation of all potential adverse effects must be recorded and
monitored throughout the study and the followup period. All adverse
effects must be documented and evaluated.
D. Statistical Analysis Plan
The involvement of a biostatistician is recommended to provide
proper guidance in the planning, design, conduct, and analysis of a
clinical study. There must be sufficient documentation of the
statistical analysis and results including comparison group selection,
sample size justification,
[[Page 61236]]
stated hypothesis test(s), population demographics, study site pooling
justification, description of statistical tests applied, clear
presentation of data and a clear discussion of the statistical results,
and conclusions.
In addition to this generalized guidance, the investigator or
sponsor is expected to incorporate additional requirements necessary
for a well-controlled scientific study. These additional requirements
are dependent on what the investigator or sponsor intends to measure or
what the expected treatment effect is based on each device's intended
use.
E. Clinical Analysis
The analysis which results from the study should include a complete
description of all the statistical procedures employed, including
assumption verification, pooling justification, population selection,
statistical model selection, etc. If any procedures are uncommon or
derived by the investigator or sponsor for the specific analysis, an
adequate description must be provided of the procedure for FDA to
assess its utility and adequacy. Data analysis and interpretations from
the clinical investigation should relate to the medical claims.
F. Monitoring
Rigorous monitoring is required to assure that the study procedures
are followed and that data are collected in accordance with the study
protocol. Forceful monitors, who have appropriate credentials and who
are not aligned with patient management or otherwise biased, contribute
prominently to a successful study.
III. Opportunity to Request a Change in Classification
Before requiring the filing of a PMA or a notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity
for interested persons to request a change in the classification of the
device based on new information relevant to its classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the act.
A request for a change in the classification of the partially
fabricated denture kit is to be in the form of a reclassification
petition containing the information required by Sec. 860.123 (21 CFR
860.123), including information relevant to the classification of the
device, and shall, under section 515(b)(2)(B) of the act, be submitted
by December 14, 1995.
The agency advises that, to ensure timely filing of any such
petition, any request should be submitted to the Dockets Management
Branch (address above) and not to the address provided in
Sec. 860.123(b)(1). If a timely request for a change in the
classification of the partially fabricated denture kit is submitted,
the agency will, by January 29, 1996, after consultation with the
appropriate FDA advisory committee and by an order published in the
Federal Register, either deny the request or give notice of its intent
to initiate a change in the classification of the device in accordance
with section 513(e) of the act and 21 CFR 860.130 of the regulations.
IV. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Ad Hoc Committee for the Delivery of Quality Prosthetic Care
for the Financially Disadvantaged, ``Final Report from the Ad Hoc
Committee for the Delivery of Quality Prosthetic Care for the
Financially Disadvantaged,'' Journal of the American Dental
Association, 95:1026-1037, November 1977.
2. Chasens, A. I., ``Controversies in Occlusion,'' Dental
Clinics of North America, 34:1:111-123, January 1990.
3. Council on Dental Materials and Devices, ``Association
Reports: Partially Prefabricated Dentures,'' Journal of the American
Dental Association, 98(2):268, February 1979.
4. Council on Dental Materials and Devices, ``Partially
Prefabricated Dentures,'' Journal of the American Dental
Association, 93(2):380, August 1976.
5. Council on Dental Materials and Devices, ``Reports of
Councils and Bureaus: Partially Prefabricated Dentures,'' Journal of
the American Dental Association, 90(3):669, March 1975.
6. Craig, R. G. et al., ``Dental Materials Properties and
Manipulation,'' pp. 271-281, 5th ed., Mosby, St. Louis, MO, 1991.
7. Muzyka, B. C., and M. Glick, ``A Review of Oral Fungal
Infections and Appropriate Therapy,'' Journal of the American Dental
Association, 126:63-72, January 1995.
8. Phillips, R. W., ``Elements of Dental Materials For Dental
Hygienists and Assistants,'' 3d ed., W. B. Saunders Co., 1977, pp.
130-138.
9. Shay, K., ``Identifying the Needs of the Elderly Dental
Patient: The Geriatric Dental Assessment,'' Dental Clinics of North
America, 38:3:499, 505-507, July 1994.
10. Vining, R. V., ``Council Comments on Prefabricated
Dentures,'' a Letter to the Editor, Journal of the American Dental
Association, 95:21, July 1977.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
VI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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 consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so 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. Because this device has been classified into class
III since August 12, 1987, and manufacturers of this device legally in
commercial distribution before May 28, 1976, or found by FDA to be
substantially equivalent to such a device, will be permitted to
continue marketing during FDA's review of the PMA or notice of
completion of the PDP, the agency certifies that the proposed rule will
not have a significant economic impact on a substantial number of small
entities. Therefore, under the Regulatory Flexibility Act, no further
analysis is required.
VII. Comments
Interested persons may, on or before February 27, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Interested
persons may, on or before December 14, 1995, submit to the Dockets
Management Branch a written request to change the classification of the
partially fabricated denture kit. Two copies of any request are to be
submitted, except that individuals may submit one copy. Comments or
requests
[[Page 61237]]
are to be identified with the docket number found in brackets in the
heading of this document. Received comments and requests may be seen in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
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 as follows:
PART 872--DENTAL DEVICES
1. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 872.3600 is amended by revising paragraph (c) to read as
follows:
Sec. 872.3600 Partially fabricated denture kit.
* * * * *
(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 on or before
(date 90 days after the effective date of a final rule based on this
proposed rule), for any partially fabricated denture kit that was in
commercial distribution before May 28, 1976, or that has on or before
(date 90 days after the effective date of a final rule based on this
proposed rule), been found to be substantially equivalent to a
partially fabricated denture kit that was in commercial distribution
before May 28, 1976. Any other partially fabricated denture kit shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.
Dated: October 5, 1995.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 95-29083 Filed 11-28-95; 8:45 am]
BILLING CODE 4160-01-F