International Workshop on the Standardization of Whole Blood Coagulation Devices

[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Notices]
[Pages 41939-41940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


International Workshop on the Standardization of Whole Blood 
Coagulation Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
workshop entitled ``International Workshop on the Standardization of 
Whole Blood Coagulation Devices.'' The focus of the workshop is to 
define the issues relating to the calibration of whole blood 
coagulation assays. Workshop participants will be asked to develop a 
proposal for standardizing the calibration of these devices. The 
proposal will be referred to a standards development organization.

DATE: The workshop will be held on August 13, 1999, 1 p.m. to 6 p.m.

ADDRESSES: The workshop will be held at the Washington Plaza Hotel, 10 
Thomas Circle NW., Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Sheila J. Murdock, Office of 
Surveillance and Biometrics (HFZ-510), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-594-3060, FAX 301-594-2968, e-mail 
``coagulation@cdrh.fda.gov''.

SUPPLEMENTARY INFORMATION: Whole blood clotting assays are used 
increasingly in the point of care testing environment. The calibration 
of these assays against plasma methods is achieved through a variety of 
approaches. Consequently, the consistency of results between different 
devices and the traceability of results to plasma methods are variable. 
Limited correlation between assays can be particularly problematic when 
monitoring anticoagulant drugs.
    The workshop will focus on defining the issues relating to the 
calibration of whole blood coagulation devices. Workshop participants 
will collaborate on a proposal for the development of a standardized 
approach to the calibration of these assays. The proposal will be 
referred to a standards development organization.
    In order to make the best use of limited workshop time, guest 
speakers will be asked to write a draft standardization proposal prior 
to the date of the workshop. This document will be posted on the CDRH 
website after July 15, 1999, at ``http://www.fda.gov/cdrh/meetings/
coag.html''. Members of the public will be encouraged to e-mail 
comments and recommendations about this document to 
``coagulation@cdrh.fda.gov''. Summaries of all e-mailed comments sent 
with author's name will be posted to the website in order to provide a 
forum for ongoing discussion up to the week of the workshop.
    Those persons interested in attending the workshop should fax or e-
mail their registration including name, title, affiliation (i.e., end-
user, government nonregulatory, government regulatory, industry, 
professional organization, proficiency testing organization, trade 
press, standards development organization), mailing address, telephone 
number, fax number, e-mail address, and area of interest. There is no 
charge to attend the workshop, however, advance registration is 
requested due to limited seating. If you need special accommodations 
due to a disability, please contact Shirley L. Meeks at least 7 days in 
advance of the meeting, at the Office of Systems Management (HFZ-17), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1283, 
ext. 105, FAX 301-827-2929, e-mail ``[email protected]''.
    Registration forms and the preliminary agenda may also be accessed 
at the CDRH website at ``http://www.fda.gov/cdrh/meetings/coag.html''. 
The workshop agenda includes presentations by guest speakers, small 
breakout group discussions and deliberation and refining of a 
standardization proposal. The final plenary session will include 
reports to the assembly from the smaller group discussions. Time will 
be provided for public comments at the end of this session. The draft 
standardization proposal will be finalized according to the

[[Page 41940]]

recommendations of workshop participants. A summary report of the 
workshop will be available on CDRH's website approximately 15 working 
days after the workshop. The CDRH home page may be accessed at ``http:/
/www.fda.gov/cdrh''.

    Dated: July 23, 1999.
 Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-19689 Filed 7-30-99; 8:45 am]
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