94-14213. The Use of Immunohistochemical Devices in the Clinical Care of Patients; Notice of Public Workshop
[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]
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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.
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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
Document Information
- Published:
- 06/10/1994
- Department:
- Food and Drug Administration
- Entry Type:
- Uncategorized Document
- Action:
- Notice of public workshop.
- Document Number:
- 94-14213
- 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.
- Pages:
- 0-0 (1 pages)
- Docket Numbers:
- Federal Register: June 10, 1994
- CFR: (1)
- 21 CFR None