[Federal Register Volume 67, Number 218 (Tuesday, November 12, 2002)]
[Rules and Regulations]
[Pages 68510-68512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28549]


=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
intraoral devices for snoring and/or obstructive sleep apnea into class 
II (special controls). These devices are used to control or treat 
simple snoring and/or obstructive sleep apnea. This classification is 
based on the recommendations of the Dental Devices Panel (the Panel), 
and is being taken to establish sufficient regulatory controls that 
will provide reasonable assurance of the safety and effectiveness of 
these devices. This action is being taken under the Federal Food, Drug, 
and Cosmetic Act (the act), as amended by the Medical Device Amendments 
of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 
(the SMDA), and the Food and Drug Administration Modernization Act of 
1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is 
publishing a notice of availability of the guidance document that will 
serve as the special control for this final rule.

DATES: This rule is effective December 12, 2002.

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 act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and the 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), are generally referred to as preamendments devices, and 
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.

[[Page 68511]]

    Devices that were not in commercial distribution prior to May 28, 
1976, are generally referred to as postamendments devices, and 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 the 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, regarding the classification of these 
devices.

II. Regulatory History of the Device

    In the Federal Register of April 5, 2002 (67 FR 16338), FDA issued 
a proposed rule to classify the intraoral devices for snoring and/or 
obstructive sleep apnea, used to control or treat simple snoring and/or 
obstructive sleep apnea into class II. The agency also issued a 
guidance document as the special control. Interested persons were given 
until July 5, 2002, to comment on the proposed regulation and guidance 
document.
    FDA received one comment from the National Association of Dental 
Laboratories.

III. Summary of Final Rule

    As required by 21 CFR 860.84(g)(2) of the regulations, FDA is 
classifying intraoral devices for snoring and/or obstructive sleep 
apnea into class II with the guidance document ``Class II Special 
Controls Guidance Document: Intraoral Devices for Snoring and/or 
Obstructive Sleep Apnea'' (Ref. 1), as the special control.

IV. Analysis of Comment and FDA's Response

    The one comment FDA received expressed concerns about the effect 
the guidance document would have on dental laboratories. FDA has 
concluded that the guidance document does not change the regulatory 
requirements for dental laboratories.
    Therefore, under section 513 of the act, FDA is adopting the 
summary of reasons for the Panel's recommendation and the summary of 
data upon which the Panel's recommendation is based, in their entirety. 
FDA also agrees with the Panel's assessment of the risks to public 
health stated in the proposed rule published on April 5, 2002. FDA is 
issuing this final rule, which classifies these generic type of 
intraoral devices for snoring and obstructive sleep apnea into class 
II.

V. 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 environment 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the final 
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. The classification of these devices into class II is 
not adding any additional burden to manufacturers, because most 
manufacturers, including small manufacturers, are already substantially 
in compliance with the recommendations of the guidance document that is 
the special control for the devices. The agency, therefore, certifies 
that this final rule will not have a significant economic impact on a 
substantial number of small entities. In addition, this final 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 of analysis under section 202(a) of the 
Unfunded Mandates Reform Act of 1995 is not required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) 
is not required.

IX. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, and may be seen by interested persons between 9 a.m. and 4 p.m., 
Monday through Friday.
    1. FDA, Center for Devices and Radiological Health, Office of 
Device Evaluation, ``Class II Special Controls Guidance Document: 
Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; 
Guidance for Industry and FDA,'' April 5, 2002.

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, 21 CFR part 
872 in subpart F is amended as follows:

PART 872--DENTAL DEVICES

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


[[Page 68512]]


    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; Guidance for Industry and FDA.''

    Dated: October 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28549 Filed 11-8-02; 8:45 am]
BILLING CODE 4160-01-S