[Federal Register Volume 59, Number 111 (Friday, June 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14213]


[[Page Unknown]]

[Federal Register: June 10, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

 

The Use of Immunohistochemical Devices in the Clinical Care of 
Patients; Notice of Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to discuss the use of immunohistochemical devices in the 
clinical care of patients. In addition, FDA is interested in obtaining 
comments on the regulation of products used in immunohistochemical 
tests.

DATES: The public workshop will be held on June 28 and 29, 1994, from 
8:30 a.m. to 5 p.m. Those interested in making a formal presentation 
must submit a written request by June 20, 1994.

ADDRESSES: The public workshop will be held at the Gaithersburg Hilton 
Hotel, 620 Perry Pkwy., Gaithersburg, MD. There is no registration fee, 
but interested persons should call the contact person listed below to 
preregister. Public participation is welcomed. Anyone wishing to make a 
formal presentation for inclusion in the workshop should submit a 
request accompanied by an outline of comments to Max Robinowitz 
(address listed below).

FOR FURTHER INFORMATION CONTACT: Max Robinowitz, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-3084, FAX 301-594-2360.

SUPPLEMENTARY INFORMATION: Developments in the use of monoclonal 
antibodies in immunohistochemical devices which are used as an aid in 
the diagnosis and management of a variety of diseases, including 
neoplasms, make it appropriate to reassess FDA's regulation of these 
devices. Among the major topics scheduled for discussion are: (1) The 
role of immunohistochemical products in cancer diagnosis; (2) problems 
associated with the use of monoclonal antibodies in immunohistochemical 
techniques; (3) the role of training and proficiency; (4) proposed role 
of the Biological Stain Commission in technical certification of 
immunohistochemical antibodies; (5) discussion on a proposal for the 
classification of immunohistochemical antibodies as class II medical 
devices; and (6) draft points to consider and guidance for the 
regulation of immunohistochemical antibodies.

    Dated: June 7, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-14213 Filed 6-7-94; 4:36 pm]
BILLING CODE 4160-01-F