[Federal Register: November 12, 2002 (Volume 67, Number 218)]
[Rules and Regulations]
[Page 68510-68512]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no02-6]
=======================================================================
-----------------------------------------------------------------------
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