[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Proposed Rules]
[Pages 16338-16341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 02N-0010]


Dental Devices; Classification for Intraoral Devices for Snoring 
and/or Obstructive Sleep Apnea

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify the intraoral devices for snoring and/or obstructive sleep 
apnea, used to control or treat simple snoring and/or obstructive sleep 
apnea. Under the proposal, the intraoral devices for snoring and/or 
obstructive sleep apnea would be classified into class II (special 
controls). The agency is publishing in this document the 
recommendations of the Dental Devices Panel (the Panel) regarding the 
classification of these devices. After considering public comments on 
the proposed classification, FDA will publish a final regulation 
classifying these devices. This action is being taken to establish 
sufficient regulatory controls that will provide reasonable assurance 
of the safety and effectiveness of these devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a notice of 
availability of a draft guidance document that would serve as the 
special control if this proposal becomes final.

DATES: Submit written or electronic comments by July 5, 2002. See 
section VII of this document for the proposed effective date of a final 
rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Susan Runner, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) established three 
categories (classes) of devices, depending on the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by FDAMA; or (3) FDA issues an order finding the 
device to be substantially equivalent, under section 513(i) of the act, 
to a predicate device that does not require premarket approval. The 
agency determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Consistent with the act and the regulations, FDA consulted with the 
Panel, an FDA advisory committee,

[[Page 16339]]

regarding the classification of the devices.
    Snoring devices were marketed prior to the enactment of the 1976 
amendments. Intraoral devices to treat snoring are removable medical 
devices that are fitted in the patient's mouth to reduce or eliminate 
snoring. In some cases, the devices may also be used to treat 
obstructive sleep apnea. Intraoral devices to treat snoring and 
obstructive sleep apnea include three basic designs: Mandibular 
repositioners, tongue retaining devices, and palatal lifting devices. 
The treatment is viewed as a noninvasive and reversible treatment 
option. All of these devices provide the same therapeutic goal of 
increasing the pharyngeal space to improve the patient's ability to 
exchange air. The increase in airway space decreases the air 
turbulence, which is a causative factor in snoring. In addition to the 
removable devices, there are implantable screw devices that may be used 
with a suturing technique as part of a surgical procedure to lift the 
intraoral musculature and provide improved oropharyngeal patency 
(airway space). Implanted screw devices are not included in this 
classification. Extraoral devices, such as nasal dilators, are 
classified separately as ear, nose, and throat devices and are not 
included in this classification.
    Recently, an increase in interest from the dental community to 
provide treatment for patients who snore or who have obstructive sleep 
apnea has resulted in an influx of premarket notification submissions 
for these devices to the agency. The majority of these new devices are 
designed as mandibular repositioners. The sponsors of these devices 
primarily seek claims for the reduction of simple snoring, although 
some seek claims for treatment of sleep apnea. Review of these devices 
includes an analysis of the devices' specific intended use(s) and 
safety considerations relating to the design and manufacturing 
materials.

II. Recommendations of the Panel

    During a public meeting which was held on November 5, 1997, the 
Panel made the following recommendations regarding the classification 
of intraoral devices for snoring and/or obstructive sleep apnea.

A. Identification

    The Panel recommended that intraoral devices for snoring and/or 
obstructive sleep apnea be identified as devices that are worn over the 
natural teeth (not dentures) to improve oropharyngeal patency (airway 
space). The devices are intended to reposition and support the mandible 
in a more forward position, lift the soft palate, or retain and support 
the tongue and its associated musculature to increase airway space. 
With an increase in airway space, there is less air turbulence, 
resulting in a decrease in snoring. In patients who also suffer from 
obstructive sleep apnea, the resulting increase in airway space 
functions to diminish apneic episodes.

B. Recommended Classification of the Panel

    The Panel unanimously recommended that the intraoral devices for 
snoring and the intraoral devices for snoring and obstructive sleep 
apnea be classified into class II. The Panel believed that class II 
with a guidance document as the special control would provide 
reasonable assurance of the safety and effectiveness of the devices. 
The Panel believed that the guidance document should address labeling 
and advised that the labeling include the following:
1. Precautions
     Use of the device may cause tooth movement or changes in 
dental occlusion.
     Use of the device may cause gingival or dental soreness.
     Use of the device may cause pain or soreness to the 
temporomadibular joint (TMJ).
     Use of the device may cause obstructed oral breathing.
     Use of the device may cause excessive salivation.
2. Contraindications
     The device should not be used in patients who have loose 
teeth or advanced periodontal disease.
     The device is contraindicated for patients who have 
congested nasal passages.
     The device should not be used in patients who are still 
growing.
     The device is not indicated for patients who have central 
sleep apnea.

C. Summary of Reasons for Recommendation

    After reviewing the information provided by FDA and considering the 
open discussions during the Panel meeting and the Panel members' 
personal knowledge of and clinical experience with the devices, the 
Panel gave the following reasons in support of its recommendation to 
classify the generic type of intraoral devices for snoring and 
intraoral devices for snoring and obstructive sleep apnea used to 
improve oropharyngeal patency into class II:
    1. The Panel believes that intraoral devices for snoring and 
intraoral devices for snoring and obstructive sleep apnea should be 
classified into class II because special controls, in addition to 
general controls, would provide reasonable assurance of the safety and 
effectiveness of the devices, and there is sufficient information to 
establish special controls to provide such assurance.
    2. The Panel believes that the benefits to health from use of the 
devices outweigh any of the known risks.
    3. The Panel agrees with FDA that sufficient data already exists to 
support safe and effective use of these devices for patients who wish 
to treat or control simple snoring due to partial obstruction of the 
airway.

D. Summary of Data Upon Which the Recommendation is Based

    Snoring is a medical and social problem that can cause patients and 
their partners to sleep poorly. This often causes excessive daytime 
drowsiness.
    During the Panel meeting, a practitioner and researcher of sleep 
disorder medicine testified that many patients experience relief from 
obstructive sleep apnea and simple snoring with the use of intraoral 
devices (Ref. 1, pp. 208-214). A trade association published a 
literature review on the use of oral devices for the treatment of 
snoring (Ref. 3). The review analyzed a compilation of 21 publications 
covering 320 patients. The authors concluded that despite the 
variations in device design, the results consistently demonstrated an 
improvement in snoring, and often eliminated snoring with the use of 
oral devices. The authors also reported that complications are rare and 
that long-term compliance varies from 50 to 100 percent of patients.
    An analysis of risk factors for mortality in sleep apnea patients 
suggests that sleep apnea syndrome contributes indirectly to mortality, 
most likely as a risk factor for hypertension (Ref. 5). Another study 
reports that there is an association between mortality and impaired 
respiration in an aged population during sleep (Ref. 4).
    According to representatives of the Sleep Disorders Dental Society, 
the success rate of these devices is well documented (Ref. 1, pp. 34-
42). In one study, the role of mandibular repositioning oral appliances 
in the treatment of obstructive sleep apnea was reported. The study 
evaluated patients with obstructive sleep apnea and concluded that the 
devices are useful in long-term treatment of patients with mild to 
moderate obstructive sleep apnea (Ref. 2).

[[Page 16340]]

    Another study compared oral devices to nasal continuous positive 
airway pressure (C-PAP) (Ref. 6). The authors reported that oral 
appliance therapy is an effective treatment for some patients who 
suffer from mild to moderate obstructive sleep apnea and noted that 
fewer side effects existed. The study also revealed that patients 
reported greater satisfaction from the use of the oral devices than 
those who were treated with nasal C-PAP.

E. Risks to Health

    Intraoral snoring and obstructive sleep apnea devices may present 
moderate risks to health. The Panel identified the following risks they 
believe the use of intraoral devices present: Dental soreness, gingival 
soreness, TMJ dysfunction syndrome, obstruction of oral breathing, and 
tooth movement.
    Dental or gingival soreness may result from pressure on oral 
structures while wearing a mandibular repositioning device. Soreness of 
palatal tissues may result from palatal lifting devices. TMJ 
dysfunction syndrome may result from use of the devices if the TMJ is 
strained or if the muscular attachments are stretched for prolonged 
periods. Joint dysfunction or discomfort may occur from unfavorable 
loading even if the mandible is repositioned appropriately. Oral 
appliances that do not include a breathing space can completely 
obstruct oral breathing, forcing the patient to breathe through the 
nose. Loosening or flaring of lower anterior teeth or general tooth 
movement may result when a mandibular repositioning device exerts 
pressure on the teeth. Periodontally compromised teeth are especially 
susceptible to flaring.
    On the basis of its review of the literature and the Panel's 
recommendation that these devices be classified into class II, FDA 
believes that intraoral snoring and/or obstructive sleep apnea devices 
do not present an unreasonable risk to health and that the guidance, 
``Class II Special Controls Guidance Document: Intraoral Devices for 
Snoring and/or Obstructive Sleep Apnea,'' as a special control, in 
addition to general controls, would provide reasonable assurance of the 
safety and effectiveness of the devices.

F. Special Control

    Based on the available information, FDA believes that, in addition 
to general controls, the guidance document, ``Class II Special Controls 
Guidance Document: Intraoral Devices for Snoring and/or Obstructive 
Sleep Apnea; Draft Guidance for Industry and FDA,'' is adequate to 
address the risks to health identified above. As discussed below, 
sections of the guidance address the risks to health by providing 
material composition and biocompatibility recommendations, providing 
labeling recommendations, describing when clinical data are needed, and 
identifying the kinds of clinical observations that should comprise 
these data. Other sections identify the kinds of material composition 
and biocompatibility information that address the risks to health.
1. Material Composition and Biocompatibility
    Material composition and biocompatibility recommendations in the 
guidance document help prevent intraoral gingival, palatal, or dental 
soreness by ensuring that materials used in these devices can maintain 
dimensional stability, do not leech any chemical compounds into the 
oral cavity, and have patient contacting surfaces appropriate to the 
design of the device.
2. Labeling
    Labeling recommendations in the guidance document include 
contraindications, warnings, precautions, and adequate directions for 
fitting, use, and care of these devices. FDA believes that these 
labeling recommendations help ensure that these devices are used 
correctly by patients for whom these devices are appropriate.
3. Clinical Data
    When clinical data are necessary, they should demonstrate a 
reduction in snoring and/or reduction in apneic episodes for intraoral 
devices for snoring and/or obstructive sleep apnea, respectively. 
Reduction in snoring should be based on clinical observation. Reduction 
in apneic episodes should be based on baseline and post-insertion 
polysomnograms that include measurements of the respiratory disturbance 
index, apnea index, duration of the apnea, and oxygen saturation.
    FDA believes that compliance with the recommendations in the 
guidance document, when combined with the general controls, will 
provide reasonable assurance of the safety and effectiveness of 
intraoral devices for snoring and/or obstructive sleep apnea.

III. Proposed Classification

    FDA believes the intraoral devices for snoring and/or obstructive 
sleep apnea should be classified into class II because the special 
control, in addition to general controls, would provide reasonable 
assurance of the safety and effectiveness of the devices, and there is 
sufficient information to establish special controls to provide such 
assurance.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) 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.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4)). 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. Manufacturers of unclassified preamendments devices 
are already subject to the general controls of the act including 
premarket notification. FDA believes that manufacturers, including 
small manufacturers, are already substantially in compliance with the 
recommendations in the guidance document that would be the special 
control for the device. FDA, therefore, believes that the rule will 
impose no significant economic impact on any small entities. The agency 
therefore certifies that this proposed rule, if issued, will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this proposed rule will not impose costs of $100 million 
or more on either the private sector or State, local, and tribal 
governments in the aggregate, and therefore a summary statement or 
analysis under section 202(a) of the

[[Page 16341]]

Unfunded Mandates Reform Act of 1995 is not required.

VI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains 
noinformation that is subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995.

VII. Submission of Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this proposed 
rule by July 5, 2002. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday. FDA proposes 
that any final regulation that may issue based on this proposal become 
effective 30 days after its date of publication in the Federal 
Register.

VIII. 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. Transcript of the Dental Products Panel Meeting, November 3-
5, 1997.
    2. Menn, S. et al., ``The Mandibular Repositioning Device: Role 
in the Treatment of Obstructive Sleep Apnea,'' Sleep, vol. 19, no. 
10, pp. 794-800, 1996.
    3. Schmidt-Nowara, W. et al., ``Oral Appliances for the 
Treatment of Snoring and Obstructive Sleep Apnea: A Review,'' Sleep, 
vol. 18, no. 6, pp. 501-510, 1995.
    4. Bliwise, D. L. et al., ``Sleep Apnea and Mortality in an Aged 
Cohort,'' American Journal of Public Health, vol. 78, no. 5, pp. 
544-547, 1988.
    5. Lavie, P. et al., ``Sleep Apnea Research Mortality in Sleep 
Apnea Patients: A Multivariate Analysis of Risk Factors,'' Sleep, 
vol. 18, no. 3, pp. 149-157, 1995.
    6. Ferguson, K. A. et al., ``A Randomized Crossover Study of an 
Oral Appliance vs. Nasal-Continuous Positive Airway Pressure in the 
Treatment of Mild-Moderate Obstructive Sleep Apnea,'' Chest, vol. 
109, no. 5, pp. 1269-1275, 1996.

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 in subpart F as follows:

PART 872--DENTAL DEVICES

    1. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 872.5570 is added to subpart F to read as follows:


Sec. 872.5570  Intraoral devices for snoring and intraoral devices for 
snoring and obstructive sleep apnea.

    (a) Identification. Intraoral devices for snoring and intraoral 
devices for snoring and obstructive sleep apnea are devices that are 
worn during sleep to reduce the incidence of snoring and to treat 
obstructive sleep apnea. The devices are designed to increase the 
patency of the airway and to decrease air turbulence and airway 
obstruction. The classification includes palatal lifting devices, 
tongue retaining devices, and mandibular repositioning devices.
    (b) Classification. Class II (special controls). The special 
control for these devices is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Intraoral Devices for Snoring 
and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA.''

    Dated: February 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8347 Filed 4-4-02; 8:45 am]
BILLING CODE 4160-01-S