[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Proposed Rules]
[Pages 30032-30037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 95N-0033]
Dental Devices; Effective Date of Requirement for Premarket
Approval of Endodontic Dry Heat Sterilizer
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 the endodontic
dry heat sterilizer, a medical device. The agency also is summarizing
its proposed findings regarding the degree of risk of illness or injury
designed to be eliminated or reduced by requiring the device to meet
the statute's approval requirements, and the benefits to the public
from use of the device. 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: Written comments by September 5, 1995; requests for a change in
classification by June 22, 1995. FDA intends that, if a final rule
based on this proposed rule is issued, PMA'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: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4765.
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 both 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, a preamendments device, subject to the
rulemaking procedure under section 515(b) of the act, is not required
to have an approved investigational device exemption (IDE) (21 CFR part
812) contemporaneous with its interstate distribution until the date
identified by FDA in the final rule requiring the submission of a PMA
for the device.
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 [[Page 30033]] 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 issuance
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 endodontic dry heat
sterilizers.
The act does not permit an extension of the 90-day period after
issuance 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 Endodontic Dry Heat Sterilizers
In the Federal Register of August 12, 1987 (52 FR 30082), FDA
issued a final rule (Sec. 872.6730 (21 CFR 872.6730)) classifying the
endodontic dry heat sterilizer into class III. The preamble to the
proposal to classify the device published in the Federal Register of
December 30, 1980 (45 FR 86155), included the recommendation of the
Dental Device Classification Panel (the panel), of the Medical Devices
Advisory Committee, an FDA advisory committee, regarding the
classification of the device.
The panel recommended that the device be in class III (premarket
approval) because the device presented an unreasonable risk of illness
or injury. According to the panel, the devices failed to sterilize
adequately various endodontic and dental instruments. The panel felt
that the failures could be the result of: (1) The device not reaching
and maintaining an adequate temperature because of a faulty thermostat
or (2) the result of unequal heat distribution by the glass beads
throughout the well despite sufficient heat. The panel believed that it
was not possible to establish an adequate performance standard for the
device because satisfactory performance had never been demonstrated.
The panel recommended the device to be subject to premarket approval to
assure that manufacturers of the device demonstrate satisfactory
performance and that further study was necessary to determine the
causes of the device's ineffectiveness.
FDA agreed with the panel's recommendation that endodontic dry heat
sterilizers be classified into class III. FDA believed that there was
an unreasonable risk of illness or injury because of the potential
failure of the device to sterilize dental instruments adequately. FDA
believed that there was inadequate information to determine if general
controls or a performance standard would provide reasonable assurance
of safety and effectiveness.
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 endodontic dry heat sterilizer within 90 days after
issuance of any final rule based on this proposal. An applicant whose
device was legally in commercial distribution before May 28, 1976, or
has been found by FDA to be substantially equivalent to such a device,
will be permitted to continue marketing the endodontic dry heat
sterilizer 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 for 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 endodontic dry heat sterilizer which is: (1) Not legally on the
market on or before that date; (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 (3) for which PMA approval has been denied or
withdrawn.
If a PMA or a notice of completion of a PDP for the endodontic dry
heat sterilizer is not filed with FDA within 90 days after the date of
issuance of any final rule requiring premarket approval for the device,
commercial distribution of the device must cease. The device may be
distributed for investigational use only if the requirements of the IDE
regulations are met. FDA would not consider an investigation of an
endodontic glass bead sterilizer to pose a significant risk as defined
in the IDE regulation provided that instruments processed in the device
are terminally sterilized by a sterilization process which can be
biologically monitored, such as steam, ethylene oxide, or dry heat. If
the investigation cannot be so designed, the investigation would
constitute a significant risk. The requirements for significant risk
devices include submitting an IDE application to FDA for its review and
approval. An approved IDE is required to be in effect before an
investigation of the device may be initiated or continued. FDA,
therefore, cautions that 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 avoid interrupting investigations.
C. Description of Device
Endodontic dry heat sterilizers are small electrically heated dry
heat sterilizers with a central well containing a heat transfer medium.
The types of [[Page 30034]] heat transfer media used in these units
have included glass beads, molten metal, metal beads, and salt. The
instruments which are to be sterilized are inserted directly into the
heat transfer medium. The units are defined in Sec. 872.6730 as devices
used to sterilize endodontic and other dental instruments by the
application of dry heat which is supplied by the glass beads which have
been heated by electricity.
The proposed rule to require premarket approval of the endodontic
dry heat sterilizer applies to devices that were being commercially
distributed before May 28, 1976, and to devices that were introduced
into commercial distribution since that date which have been found to
be substantially equivalent to predicate endodontic dry heat
sterilizers.
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 endodontic dry
heat sterilizers 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
The panel identified the primary risk to health as infection by
stating that ``The inability of the device to sterilize adequately
endodontic and other dental instruments may lead to transmission of
microorganisms among patients and subsequent spread of infection.''
A review of the literature on endodontic dry heat sterilizers has
identified the following problems associated with the use of these
devices which contribute to the inability of endodontic dry heat
sterilizers to sterilize instruments, including general medical
instruments.
1. Temperature Variation Within the Well
There are many reports in the literature describing the temperature
variation found within the wells of glass bead sterilizers (Refs. 2, 3,
4, 7, 10, and 11). Engelhardt et al. (Ref. 4) measured the temperature
distribution in four brands of glass bead sterilizers at two different
sites from the center and at six different depths in the well. He
reported that the temperature within the well varied significantly
depending upon location. The temperature was highest closest to the
wall and midway down from the surface (Ref. 4). Corner also reported
that near the periphery of the well the temperature varied by as much
as 10 deg.C over time (Ref. 5). According to Ingle, glass bead
sterilizers should not be used as a substitute for dry heat convection
or steam sterilizers because of the temperature variations (Ref. 7).
2. Lack of Methods to Monitor the Recommended Exposure Times for
Sterilization of the Instruments
The manufacturers' recommended exposure times for sterilization of
instruments vary from as short as 2 seconds to 45 seconds for
sterilizers whose purported operating temperatures are from 218 deg.C
to 260 deg.C. However, location of the instruments in the well, the
size and mass of the instruments, the number of instruments, and the
shape of the instruments must be factored into the amount of time
required for sterilization. Larger instruments composed of more metal
take more time to heat than smaller instruments. Koehler reported that
the time required to raise an instrument's temperature was dependent
upon its size. Small instruments such as root canal files heated
rapidly, while large instruments such as cotton pliers never reached
the specified operating temperature (Ref. 6). Corner reported that
instruments such as forceps, scalpels, spatulas, and scissors
sterilized in rapid succession caused the temperature in the well to
drop an average of 7 deg.C for each instrument and that it took 15
minutes for the temperature of the well to recover (Ref. 2). Smith
reported sterilization times of 15 seconds to kill orthodontic bands
contaminated with Staphylococcus albus and 45 seconds for bands
contaminated with Bacillus subtilis spores; but if five bands were
sterilized simultaneously, then the sterilization times doubled (Ref.
10). Fahid reported that a No. 60 file, which was the largest file
tested in the study, was the most difficult to sterilize. The
difficulty was attributed to two factors: the large mass of the file,
and the air trapped in the deep trough since air is a poor heat
conductor (Ref. 5). Engelhardt described sterilization times for
endodontic instruments ranging from 15 to more than 100 seconds in
glass bead sterilizers, and in some cases, the 100 seconds were not
sufficient to achieve sterilization (Ref. 4). Schutt et al. found that
it took 60 seconds to sterilize dental burs. He also emphasized that
the temperature at the depth of the immersion of the burs should be
measured and that the minimum temperature should be at least 175 deg.C
at 2 millimeters (mm) below the surface and 240 deg.C at 15 mm below
the surface (Ref. 9). It has been reported in the literature that glass
bead sterilizers have been shown to be effective only with small
instruments that can be imbedded into the heat transfer media and that
their effectiveness has not been demonstrated for instruments of larger
bulk. The insertion of large instruments would reduce the temperature
of the glass beads below the minimum temperature required for
sterilization (Ref. 1). Heat conduction in a large, partially imbedded
device would be variable.
Precleaning of the instruments before insertion into the glass bead
sterilizer is critical to the effectiveness of the device. Engelhardt
demonstrated that if endodontic instruments were contaminated with a
protein load (blood), the time required for sterilization was more than
doubled. Such adverse conditions can easily be found in infected or
gangrenous pulp. Spores, which are more resistant to sterilization
processes than vegetative organisms, have been found in the oral cavity
and cultured from pulp material (Ref. 4).
3. Lack of Methods to Monitor the Performance/Sterilization Efficacy of
the Device
There are no identified methods for the routine monitoring of the
sterilization efficacy of the endodontic dry heat sterilizer such as
the ones which exist with the traditional sterilization methods, i.e.,
steam autoclaves, hot air dry heat sterilizers, or ethylene oxide
sterilizers. Chemical and biological indicators are available for
routine monitoring of the efficacy of the cycle parameters and for the
validation of the process specifications for these traditional
sterilizers. The data in the literature, as noted above, suggest that
the user can not be assured that instruments inserted into an
endodontic dry heat sterilizer will be reliably exposed to the minimum
cycle parameters required for sterilization, i.e., exposure of the
device to a set temperature for a specified time.
4. Variability of the Warm-up Times for Glass Bead Sterilizers
Reported warm-up times for these devices range from 15 minutes to
50 minutes with the average of 15-20 minutes. However, Corner reported
that it took up to 30 minutes for the temperature of the glass beads to
stabilize even though the manufacturer claimed that the device reached
operating temperature within 10 minutes (Ref. 2). [[Page 30035]]
5. Maintenance of Sterility After Removal From the Device
The instructions for use for most of the devices do not instruct
the user on the proper procedure to remove instruments from the device,
and on how to maintain sterility of the instruments or the processed
portion of the instrument during the cool down period. There also
exists the possibility that the heat transfer medium could serve as a
source of contamination between patients. Because of the reported
temperature gradients within the wells, there exists the possibility
that heat resistant microorganisms could survive in the cooler regions
near the top of the well and contaminate the instruments used upon the
next patient as they are removed from the well. Furthermore, because
endodontic dry heat sterilizers only process that portion of the
instrument which has been inserted into the glass beads, there is the
potential of contaminating a sterile field with a device which had not
been properly processed.
6. Possibility of the Heat Transfer Medium Remaining Upon The Devices
Occasionally the heat transfer media has been observed to adhere to
wet instruments. If the particles are not detected before the devices
are inserted into the site, then they could cause blockage of the wound
site or other adverse effects. This would cause significant problems if
the heat transfer media were glass beads or molten metal (Ref. 1).
F. Benefit of the Devices
The endodontic dry heat sterilizer could be used to decontaminate
endodontic instruments during a procedure on a single patient provided
the instruments are properly cleaned to remove organic debris before
insertion into the unit. In theory the number of microorganisms that
would be introduced into the same site or into a new site on the same
patient during a single procedure would be reduced. Once the procedure
is over, the instruments should be processed using traditional methods
of decontamination and sterilization before use in the next patient.
G. Need for Information for Risk/Benefit Assessment of the Device
The data in the literature indicate the lack of uniform
sterilization parameters among the various glass bead sterilizers which
have been marketed. Because of the temperature variation found within
the wells of glass bead sterilizers, exposure of an instrument to an
adequate sterilizing temperature is difficult to determine and must be
confirmed independently for each instrument. Also determination of the
sterilization exposure time is dependent upon instrument size and mass.
As Koehler noted, some instruments never reach the appropriate
temperature because of their size and mass (Ref. 6); and, as noted in
the American Dental Association's ``Accepted Dental Therapeutics,''
40th ed., endodontic dry heat sterilizers are not appropriate for large
bulk instruments (Ref. 1).
Review of the claims being made for these devices suggests that
manufacturers are expanding the claims beyond those originally defined
in Sec. 872.6730. The claims have been expanded to include the
sterilization of general medical instruments and electrolysis and
acupuncture needles, and to devices not regulated by FDA such as
manicurist's instruments. The claims imply that these devices can be
used as a substitute for the traditional methods of sterilization.
Scarlett noted that endodontic dry heat sterilizers are not
sterilizers, but are decontaminating devices and that they should not
be used to sterilize instruments between patients (Ref. 8). No system
exists for (1) Monitoring the exposure of the instrument to
sterilization conditions, or (2) demonstrating that the sterilization
exposure parameters have been achieved within the well. Only the
portion of the instrument which is inserted into the heat transfer
medium has the potential of being sterilized; the portion which is not
inserted into the glass beads is not sterilized. The use of endodontic
dry heat sterilizers with general medical instruments and with the
implication as a substitute sterilization method raises serious safety
and effectiveness questions which the manufacturers of these devices
have not adequately addressed. There is the serious risk of infection
through the use of inadequately processed instruments.
FDA believes that sufficient information may exist regarding the
risks and benefits associated with the device, but the information must
be assembled in such a way as to enable FDA to determine if the
information provides reasonable assurance of the safety and
effectiveness of the device for its intended use as defined in 21 CFR
860.7.
FDA classified the endodontic dry heat sterilizer 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 present
evidence of significant risks associated with use of the device. These
risks must be addressed by the manufacturers of endodontic dry heat
sterilizers. FDA believes that the endodontic dry heat 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. Such a PMA should also 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.
A PMA should include valid scientific evidence obtained from well-
controlled studies, with detailed data, in order to provide reasonable
assurance of the safety and effectiveness of the endodontic dry heat
sterilizer for its intended use. The data must include the following
information:
a. A general description of the sterilizer including its
specifications, process parameters and process monitors;
b. An overview of the sterilization process with accompanying
charts, graphs, or other visuals explaining all parameters;
c. A description of any test packs used in validating the
performance of the endodontic dry heat sterilizer and in routine
monitoring of the device;
d. Physical tests which demonstrate that the sterilizer achieves
and maintains the physical process lethality conditions within
specifications. The testing should describe how the process parameters
and specifications were determined;
e. The microbiological performance tests must demonstrate that the
device can sterilize to an acceptable sterilization assurance level all
medical products identified in the labeling when used in accordance
with the directions for use. The tests should be consistent with those
used to validate sterilization processes including simulated and actual
use tests;
f. Material compatibility tests must show that the medical devices
identified in the labeling are compatible with the
[[Page 30036]] sterilization process of the endodontic dry heat
sterilizer; and
g. Final qualification tests from at least three consecutive runs
under worst case loading conditions as indicated in the labeling.
Additional information about the validation of sterilization
processes can be found in: ``Guidance on Premarket Notification
(510(k)) Submissions for Sterilizers Intended for Use in Health Care
Facilities'' (available upon request from the Center for Devices and
Radiological Health, Division of Small Manufacturers Assistance (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850); the American Association of Medical Instrumentation's (AAMI)
voluntary standards describing the validation requirements for
sterilization processes; and the publication entitled ``Sterile Medical
Devices, A GMP Workshop Manual, 4th Ed., HHS Publication (FDA) 84-4147.
The PMA should contain a detailed discussion with supporting
simulated- and in-use studies, as described in the above guidance, of:
(1) All risks that have been identified in this proposed rule; and (2)
the effectiveness of the specific endodontic dry heat sterilizer that
is the subject of the application. In addition, the submission should
contain all data and information on: (1) Risks known to the applicant
that have not been identified in this proposed rule; (2) summaries of
all existing simulated- and in-use data from investigations on the
safety and effectiveness of the device for which premarket approval is
sought; and (3) the results of simulated- and in-use studies conducted
by or for the applicant. Applicants should submit any PMA in accordance
with the FDA's ``Guideline for the Arrangement and Content of a PMA
Application.'' The guideline is available from the Center for Devices
and Radiological Health, Division of Small Manufacturers Assistance
(address above).
III. Comments
Interested persons may, on or before September 5, 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. 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.
IV. Opportunity to Reguest 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 endodontic dry
heat sterilizer is to be in the form of a reclassification petition
containing the information required by Sec. 860.123 (21 CFR 860.123),
including new information relevant to the classification of the device,
and shall, under section 515(b)(2)(B) of the act, be submitted by June
22, 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 endodontic dry heat sterilizer is submitted, the
agency will, by August 7, 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.
V. 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. American Dental Association, ``Accepted Dental Therapeutics,''
40th ed., pp. 138-139, Chicago, IL, 1984.
2. Corner, G. A., ``An Assessment of the Performance of a Glass Bead
Sterilizer,'' Journal of Hospital Infection, 10:308-311, 1987.
3. Dayoub, M. B., and M. J. Devine, ``Endodontic Dry-Heat Sterilizer
Effectiveness,'' Journal of Endodontics, 2:343-344, 1976.
4. Engelhardt, M. P., L. Grun, and H. Dahl, ``Factors Affecting
Sterilization in Glass Bead Sterilizers,'' Journal of Endodontics,
10:454-470, 1984.
5. Fahid, A., and J. F. Tainter, ``The Influence of File Size,
Cleaning, and Time on the Effectiveness of Bead Sterilizers,'' Oral
Surgery, 58:443-445, 1984.
6. Koehler, H. M., and J. J. Hefferren, ``Time-Temperature Relations
of Dental Instruments Heated in Root-Canal Instrument Sterilizers,''
Journal of Dental Research, 41:182-195, 1962.
7. Ingle, J. I., Endodontics, 3d Ed., Philadelphia, Lea & Febiger,
pp. 615-616.
8. Jakush, J., ``Infection Control Procedures and Products: Cautions
and Common Sense,'' Journal of The American Dental Association,
117:293-301, 1988.
9. Schutt, R. W., and W. J. Starsiak, ``Glass Bead Sterilization of
Surgical Dental Burs,'' International Journal of Oral and
Maxillofacial Surgery, 19:250-251, 1990.
10. Smith, G. E., ``Glass Bead Sterilization of Orthodontic Bands,''
American Journal of Orthodontics Dentofacial Orthopedics, 90:243-
249, 1986.
11. Windeler, A. S., and R. G. Walter, ``The Sporicidal Activity of
Glass Beads Sterilizers,'' Journal of Endodontics, 1:273-275, 1975.
VI. 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.
VII. 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 PMA's for this device could have been
required by FDA as early as February 12, 1990, and because firms that
distributed this device prior to May 28, 1976, or whose device has been
found by FDA to be substantially equivalent will be permitted to
continue marketing the endodontic dry heat sterilizer during FDA's
review of the PMA or notice of completion of the [[Page 30037]] 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.
List of Subjects in 21 CFR Part 872
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the 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 is revised to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,
360e, 360j, 360l, 371).
2. Section 872.6730 is amended by revising paragraph (c) to read as
follows:
Sec. 872.6730
Endodontic dry heat sterilizer.
* * * * *
(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 with the Food
and Drug Administration on or before (90 days after the effective date
of a final rule based on this proposed rule), for any endodontic dry
heat sterilizer that was in commercial distribution before May 28,
1976, or that has on or before (90 days after the effective date of a
final rule based on this proposed rule), been found to be substantially
equivalent to the endodontic dry heat sterilizer that was in commercial
distribution before May 28, 1976. Any other endodontic dry heat
sterilizer shall have an approved PMA or declared completed PDP in
effect before being placed in commercial distribution.
Dated: May 24, 1995.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 95-13831 Filed 6-6-95; 8:45 am]
BILLING CODE 4160-01-P