Richard, It looks like your post # 39 of June 20th,1996 is finally making the news services. I think this investigation into the FDA rejection of Biocontrol's Diasensor 1000 could be very positive for the company. If this device should have been approved the first time, that now seems possible because of this investigation, this will put added pressure on the FDA to approve the new Revised 510K Submission for the Diasensor.--------------Best regards, Mike
Friday September 20 8:00 AM EDT
U.S. House Of Representatives To Investigate Fda
Handling Of Biocontrol Technology 510(K) Submission
PITTSBURGH, Sept. 20 /PRNewswire/ -- Biocontrol Technology Inc announced today that it has
been notified by the U.S. House of Representatives Subcommittee on Oversight and Investigations
that a hearing will be held Thursday, September 26, 1996, to examine the manner in which the Food
and Drug Administration (FDA) handled Biocontrol Technology's 510(k) submission and the
February 26, 1996 Advisory Panel Review for its Diasensor 1000(TM) noninvasive glucose sensor
for diabetics.
The decision to conduct this hearing, the Company has been informed, was based on investigations
conducted by the Subcommittee during the last several months.
The hearing will be held at 10:00 a.m. in the Rayburn House Office Building in room 2322,
Washington, D.C. and is open to the public. No further details are known by the Company at this
time.
BICO submitted its 510(k) premarket notification for the Diasensor 1000 to the FDA in January
1994.
Biocontrol Technology, Inc. has its corporate offices In Pittsburgh, PA and is involved in the
development and manufacture of biomedical devices and environmental products. SOURCE
Biocontrol Technology, Inc.
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