[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