[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