[Federal Register Volume 62, Number 198 (Tuesday, October 14, 1997)]
[Notices]
[Page 53333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27233]



[[Page 53333]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Dental Products Panel of the Medical Devices Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Dental Products Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on November 3, 1997, 9 a.m. 
to 5:30 p.m.; November 4, 1997, 8:30 a.m. to 5:30 p.m.; and November 5, 
1997, 8 a.m. to 12 m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Pamela D. Scott, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12518. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On November 3, 1997, the committee will discuss the 
previously unclassified devices for use in the diagnosis and/or 
treatment of temporomandibular joint dysfunction and oral-facial pain 
(e.g., muscle monitor devices, jaw tracking devices, TENS 
(transcutaneous electrical nerve stimulation) devices, EMG 
(electromyographic) devices, and ultrasound devices). The committee 
will provide comments on the types of devices to be included within 
this category under these indications, which will assist FDA in 
developing a comprehensive strategy for subsequent classification 
efforts. This discussion will not include previously classified devices 
such as temporomandibular joint implants. The proposed listing of 
devices to be included within this category will be placed on CDRH's 
Internet website at http://www.fda.gov/cdrh. The topical index may be 
consulted for its specific location. On November 4, 1997, the committee 
will discuss and make recommendations to FDA regarding the 
reclassification of subgroups of endosseous dental implant devices. The 
following subgroups of endosseous implants will be included: Coated and 
uncoated hollow cylinder and solid cylinder implants, coated and 
uncoated screw type implants (other than the commercially pure titanium 
screw type implant previously proposed for reclassification), coated 
and uncoated blade type implants, implants with special enhanced 
retention mechanisms and transitional implants. The coated implants may 
be further divided into porous coatings (e.g., titanium bead coatings), 
nonporous coatings (e.g., titanium plasma spray coatings), metallic 
coatings and ceramic coatings (e.g., hydroxylapatite coatings). The 
committee will also discuss and make recommendations regarding the 
classification of oral appliances for the treatment of obstructive 
sleep apnea and snoring. On November 5, 1997, the committee will 
continue discussion of the classification of oral appliances for the 
treatment of obstructive sleep apnea and snoring if time does not 
permit this issue to be completed on November 4, 1997.
    Procedure: On November 3, 1997, from 9 a.m. to 5:30 p.m.; November 
4, 1997, from 8:30 a.m. to 4:30 p.m.; and on November 5, 1997, from 8 
a.m. to 12 m., the meeting is open to the public. Interested persons 
may present data, information, or views, orally or in writing, on 
issues pending before the committee. Written submissions may be made to 
the contact person by October 27, 1997. Oral presentations from the 
public regarding devices with indications for use involving the 
diagnosis and/or treatment of temporomandibular joint dysfunction and 
oral-facial pain will be scheduled between approximately 9:30 a.m. and 
10 a.m. on November 3, 1997. Oral presentations from the public 
regarding the reclassification of subgroups of endosseous dental 
implant devices will be scheduled between approximately 8:45 a.m. and 
9:15 a.m. on November 4, 1997. Oral presentations from the public 
regarding the classification of oral appliances for the treatment of 
obstructive sleep apnea and snoring will be scheduled between 
approximately 3:15 p.m. and 3:45 p.m. on November 4, 1997. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 27, 1997, and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the November 3, 4, and 5, 1997, Dental Products Panel of the Medical 
Devices Advisory Committee meeting. Because the agency believes there 
is some urgency to bring this issue to public discussion and qualified 
members of the Dental Products Panel of the Medical Devices Advisory 
Committee were available at this time, the Commissioner concluded that 
it was in the public interest to hold this meeting even if there was 
not sufficient time for the customary 15-day public notice.
    Closed Committee Deliberations: On November 4, 1997, from 4:30 p.m. 
to 5:30 p.m., the meeting will be closed to permit discussion of trade 
secret and/or confidential information (5 U.S.C. 552b(c)(4)) regarding 
dental device issues.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-27233 Filed 10-9-97; 10:26 am]
BILLING CODE 4160-01-F