95-18450. Muscle Monitoring Devices; Decision Not to Rely on Dental Products Panel Recommendations

[Federal Register Volume 60, Number 143 (Wednesday, July 26, 1995)]
[Notices]
[Page 38363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18450]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Muscle Monitoring Devices; Decision Not to Rely on Dental 
Products Panel Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
does not intend to rely on recommendations arising out of the October 
13 and 14, 1994, meeting of the Dental Products Panel of the Medical 
Devices Advisory Committee concerning the classification of muscle 
monitoring devices. It is FDA's view that the October 1994 meeting was 
flawed and should not be the basis for decisions made about the use of 
these devices. FDA plans to fully and comprehensively consider the 
classification of muscle monitoring devices at a future meeting of the 
Dental Products Panel of the Medical Devices Advisory Committee.

FOR FURTHER INFORMATION CONTACT: Nancy J. Pluhowski, Center for Devices 
and Radiological Health (HFZ-400), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2022.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 19, 
1994 (59 FR 47880 at 47881), FDA announced that a meeting of the Dental 
Products Panel of the Medical Devices Advisory Committee would be held 
on October 13 and 14, 1994, to consider the classification of muscle 
monitoring devices. Because of substantive and procedural issues in 
connection with the October 1994 meeting, including the scope of 
products included and concerns that all interested parties may not have 
received adequate notice of the devices to be discussed at the meeting, 
FDA does not intend to rely on the Panel's discussion or 
recommendations for the use or classification of these devices. In 
addition, it is FDA's view that the October 1994 meeting should not be 
the basis for decisions about the use of these devices. FDA plans a 
full and comprehensive consideration of muscle monitoring devices at a 
future meeting of the Dental Products Panel.
    The Dental Products Panel of the Medical Devices Advisory Committee 
meeting tentatively scheduled for August 8, 9, and 10, 1995, which was 
announced in the Federal Register on March 9, 1995 (60 FR 12960 at 
12962), will not include discussion of muscle monitoring devices. FDA 
will announce future meetings of the Dental Products Panel of the 
Medical Devices Advisory Committee in the Federal Register at least 15 
days in advance of the upcoming meetings.

    Dated: July 21, 1995.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 95-18450 Filed 7-24-95; 11:46 am]
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