[Federal Register Volume 60, Number 132 (Tuesday, July 11, 1995)]
[Proposed Rules]
[Pages 35713-35718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16962]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 95N-0034]


Dental Devices; Effective Date of Requirement for Premarket 
Approval of Over-the-Counter (OTC) Denture Cushions or Pads and OTC 
Denture Repair Kits

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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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 product development protocol (PDP) for OTC denture 
cushions or pads and OTC denture repair kits. The agency is also 
summarizing its 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 devices have 
an approved PMA or a completed PDP. In addition, FDA is announcing the 
opportunity for interested persons to request the agency to change the 
classification of the device based on new information.

DATES: Submit written comments by October 10, 1995; requests for a 
change in classification by July 26, 1995. FDA intends that if a final 
rule based on this proposed rule 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 before May 28, 1976, and the substantially 
equivalent devices that were marketed 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 issues 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 

[[Page 35714]]
the investigational device exemption (IDE) regulations in 21 CFR part 
812 until the date stipulated by FDA in the final rule requiring the 
submission of a premarket approval application or a PDP for that 
device. At that time, an IDE must be submitted only if a PMA has not 
been submitted or a PDP completed.
    Section 515(b)(2)(A) of the act provides that a proceeding to issue 
a final rule to require premarket approval 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, issue 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). FDA has in 
the past requested that manufacturers take action to prevent the 
further use of devices for which no PMA has been filed and may 
determine that such a request is appropriate for OTC denture cushions 
or pads and OTC denture repair 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 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, 
94th Cong., 2d sess. 42 (1976).)

A. Classification of OTC Denture Cushions or Pads and OTC Denture 
Repair Kits

    In the Federal Register of August 12, 1987 (52 FR 30082), FDA 
issued a final rule classifying the OTC denture cushion or pad and the 
OTC denture repair kit 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 
Panel (the panel), an FDA advisory committee, regarding the 
classification of the devices. The panel recommended that the OTC 
denture cushion or pad be in class III (premarket approval) if the 
device is made of a material different from wax-impregnated cotton 
cloth, and if it is intended for a use other than short-term use. The 
1980 panel recommended that the OTC denture repair kit be in class III 
(premarket approval) for all uses. 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 a standard.
    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 
things, 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. The OTC 
denture cushion or pad and the OTC denture repair kit were not included 
in the list of devices identified in that notice. However, using those 
factors, FDA updated its priorities in a preamendments class III 
devices strategy document made public through a Federal Register Notice 
of Availability published May 6, 1994 (59 FR 23731). Accordingly, FDA 
has recently determined that the OTC denture cushion or pad identified 
in 21 CFR 872.3540 and the OTC denture repair kit identified in 21 CFR 
872.3570 have a high priority for initiating a proceeding to require 
premarket approval because the safety and effectiveness, of the devices 
have not been established by valid scientific evidence as defined in 21 
CFR 860.7. Accordingly, FDA is commencing a proceeding under section 
515(b) of the act to require that the OTC denture cushion or pad and 
the OTC denture repair kit have approved PMA's or declared completed 
PDP's.

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 OTC denture cushion or pad and the OTC denture repair 
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 OTC denture cushion or pad and the OTC denture 
repair 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 

[[Page 35715]]

``* * * the continued availability of the device is necessary for the 
public health.''
    FDA intends that, under Sec. 812.2(c)(2), 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 OTC denture cushion or pad and OTC denture repair 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 PDP is not filed by that date, or for which PMA approval 
has been denied or withdrawn.
    If a PMA, notice of completion of a PDP, or an IDE application for 
the OTC denture cushion or pad and OTC denture repair kit is not 
submitted to FDA within 90 days after the date of promulgation of any 
final rule requiring premarket approval for the device, commercial 
distribution of the device must cease. FDA, therefore, cautions that, 
for manufacturers not planning to submit a PMA immediately, IDE 
applications should be submitted to FDA at least 30 days before the end 
of the 90 day period after the final rule is published to minimize the 
possibility of interrupting all availability of the device. FDA does 
not consider an investigation of the OTC dental cushion or pad and the 
OTC denture repair 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 (21 CFR 812.1(b)) of theIDE regulation.
C. Description of Devices
    An OTC denture cushion or pad is a prefabricated or noncustom 
device that is intended to improve the fit of a loose or uncomfortable 
denture, and may be available for purchase over-the-counter. It is a 
class I device if the OTC denture cushion or pad is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth, and 
is intended to be discarded following 1 day of use. It is a class III 
device if the product is made of a material other than wax-impregnated 
cotton cloth, if it is not intended to be discarded after 1 day's use, 
and it is intended for a use other than short-term use.
    An OTC denture repair kit is a device consisting of a material, 
such as a resin monomer system of powder and liquid glues, that is 
intended to be applied permanently to a denture to mend cracks or 
breaks. The device may by available for purchase OTC.

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 the OTC 
denture cushion or pad and the OTC denture repair kit 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

1. OTC Denture Cushions or Pads
    OTC denture cushions or pads have been associated with changes in 
oral tissues, including tissue irritation, erythema, and bone 
resorption (due to the uneven pressure caused by the cushion and pad) 
(Ref. 1). There is also a risk of sensitivity to the cushion or pad 
material. Additionally, in 1980, the panel associated a potential 
unreasonable risk of illness or injury with OTC denture cushions or 
pads. The denture cushions or pads may cause an improper vertical 
dimension of a denture (Ref.2), which may result in increased occlusal 
(biting) forces and lead to bone loss through resorption (degeneration 
of the bone through gradual dissolution). The panel also believed that 
long-term irritation of oral tissue caused by incorrect vertical 
dimension could cause the formation of carcinomas. There is no recent 
evidence in the published scientific literature to suggest that these 
risks are no longer relevant.
2. OTC Denture Repair Kits
    OTC denture repair kits may cause: Altered esthetics, contact 
dermatitis, soft tissue irritation (resulting from the use of 
commercially available cements or adhesives not specifically designed 
for intraoral use), and an ill fitting denture (Refs. 3, 4, 5, and 6). 
The 1980 Dental Devices Classification panel believed that OTC denture 
repair kits presented a potential unreasonable risk of illness or 
injury. The panel advised that if the repaired denture does not have 
the same characteristics and fit as the original denture, the repaired 
denture may cause a change in the vertical dimension of the denture, 
which may result in increased occlusal (biting) forces and lead to bone 
loss through resorption (degeneration of the bone through gradual 
dissolution) (Refs. 5 and 7). The panel also believed that long-term 
irritation of oral tissue caused by incorrect vertical dimension could 
cause the formation of carcinomas. There is no new evidence in the 
published scientific literature to suggest that these risks are no 
longer relevant.

F. Benefits of the Devices

1. OTC Denture Cushion or Pad
    OTC denture cushions or pads are placed on the tissue contacting 
surface of a denture to help fill in areas where the acrylic denture 
material no longer contacts the oral tissue. The potential benefits 
intended from the use of an OTC denture cushion or pad are improvement 
in the retention, stability, and comfort of maxillary and mandibular 
dentures.
2. OTC Denture Repair Kit
    An OTC denture repair kit provides the material for repairing 
cracks or breaks in a denture, or for reattaching dislodged teeth on a 
denture to the actual consumer. The denture repair kit restores the 
function and esthetics of a denture so that the denture can continue to 
be worn.

G. Need for Information for Risk/Benefit Assessment of the Device

    FDA classified the OTC denture cushion or pad and the OTC denture 
repair kit into class III because FDA 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 devices and believes that the 
literature reports and other information discussed above suggest the 
potential for unreasonable risks associated with use of the devices. 
These risks must be addressed by the manufacturers of OTC denture 
cushions or pads and OTC denture repair kits. FDA believes that OTC 
cushions or pads and OTC denture repair 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 these devices 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 also include 

[[Page 35716]]
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 reasonably should be known 
to the applicant that have not been identified in this document; (2) 
the effectiveness of the specific OTC denture cushion or pad and OTC 
denture repair 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 21 CFR 
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 OTC denture cushion or pad and the OTC 
denture repair kit for their intended uses. 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 
following criteria. Applicants should submit any PMA in accordance with 
FDA's ``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 OTC denture cushion or pad or OTC denture repair 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 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 toxicity testing.
    5. The toxicological evaluation performed in accordance with the 
guidance should be considered in conjunction with other information 
from other nonclinical tests, clinical 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 (erythema, edema, soft tissue hyperplasia, 
ulceration, allergic response, bone resorption, or other adverse 
effects) is associated with the subject device in the patient 
population and how does this compare to the control?
    2. Is the material composition of the device compatible with the 
denture base material?
    3. Can the average consumer follow the instructions for use 
included with the device and adequately restore the function of the 
denture?
    4. What impact does the device have on the vertical dimension of 
occlusion?
    5. What are the long term effects of the device on the oral tissue?
    6. What changes in the physical characteristics (hardness, 
dimensional stability) of the materials take place over time?
    7. Does the device provide a functional level of retention for the 
user?
    8. Does the device allow sufficient comfort for the user?
    9. Does the denture repair kit provide adequate strength for the 
denture to function properly following temporary repair?
    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 of 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 excessively 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 patients were enrolled to attain 
statistically and clinically meaningful results. Eligibility criteria 
for the subject population should include the subjects' 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 heterogenous 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 devices.
    Adherence to the protocol by subjects, investigators, and all other 
individuals involved is essential and requires monitoring to assure 
compliance by 

[[Page 35717]]
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, 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 interpretation from 
the clinical investigation should relate to the medical claims.

F. Monitoring

    Rigorous monitoring is required to assure that 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 OTC denture 
cushion or pad and the OTC denture repair kit are 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 July 26, 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 OTC denture cushion or pad or the OTC denture 
repair kit is submitted, the agency will, by September 11, 1995, 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) Cinotti, W. R., et al., ``An Over-the-Counter Dental 
Cushion: A Study of Efficacy, Safety, and Compliance,'' vol. v, no. 
10, pp. 792-801, ``The Compendium of Continuing Education,'' 
November/December 1984.-
    (2)- Craig, R. G., et al., ``Dental Materials Properties and 
Manipulation,'' 5th ed., Mosby, pp. 282-283, 1992.-
    (3) Kapur, K. K., ``A clinical evaluation of denture 
adhesives,'' Journal of Prosthetic Dentistry, 10(6):550-558, 1967.-
    (4) Koudelka, B. M., et al., ``Denture self-repair: Experimental 
soft tissue response to selected commercial adhesives,'' Journal of 
Prosthetic Dentistry, 43(2):143-148, 1980.-
    (5) Ortman, L. F., ``Patient Education and Complete Denture 
Maintenance,'' Symposium on Complete Dentures, Dental Clinics of 
North America, 21(2):359-367, 1977.
    (6) Phillips, R. W., ``Elements of Dental Materials for Dental 
Hygienists and Assistants,'' 3d ed., W. B. Saudners, pp. 138-139, 
1977.-
    (7) Woelfel, J. B., et al., ``Additives sold over the counter 
dangerously prolong wearing period of ill-fitting dentures,'' 
Journal of the American Dental Association, 71(9):603-613, 1965.-

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 
environment 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 these devices have been classified into 
class III since August 12, 1987, and manufacturers of 

[[Page 35718]]
these devices that were 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 October 10, 1995, 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 July 26, 1995, submit to the Dockets 
Management Branch a written request to change the classification of the 
OTC denture cushion or pad or the OTC denture repair kit. Two copies of 
any request are to be submitted, except that individuals may submit one 
copy. Comments or requests 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 872.3540 is amended by revising paragraph (c) to read 
as follows:

Sec. 872.3540   OTC denture cushion or pad.

* * * * *
    (c)- Date premarket approval application (PMA) or notice of 
completion of product development protocol (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 OTC denture cushion or pad made of a material 
other than wax-impregnated cotton cloth, not intended to be discarded 
after 1 day's use, and intended for a use other than short-term use, 
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 an 
OTC denture cushion or pad made of a material other than wax-
impregnated cotton cloth, not intended to be discarded after 1 day's 
use, and intended for a use other than short-term use that was in 
commercial distribution before May 28, 1976. Any other OTC denture 
cushion or pad made of a material other than wax-impregnated cotton 
cloth, not intended to be discarded after 1 day's use, and intended for 
a use other than short-term use shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.
    3. Section 872.3570 is amended by revising paragraph (c) to read as 
follows:

Sec. 872.3570   OTC denture repair kit.

* * * * *
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (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 OTC denture repair 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 the OTC denture 
repair kit that was in commercial distribution before May 28, 1976. Any 
other OTC denture repair kit shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

    Dated: June 26, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-16962 Filed 7-10-95; 8:45 am]
BILLING CODE 4160-01-F