FY 2005 OIVD Annual Report - Part 2 - Guidance Development
In FY 05, OIVD issued eight guidance documents which are listed below. Among the eight, five are Special Controls guidances. In addition to these IVD-specific guidances, there are other non-IVD-specific guidances that would also apply to IVDs. All of these guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/cdrh) which provides easy access to the latest information, operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041 or 240-276-3103; Fax 240-276-3151; Email email@example.com or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307).
OIVD staff continue to play a significant role in both domestic and international standards committees. Our staff members are liaisons and chairpersons of standards committees for a wide range of devices for a variety of standards organizations including ISO and CLSI. OIVD is committed to the standards development process, and we believe that the development of scientifically sound standards will allow us to efficiently review premarket applications for both existing and innovative technologies. A complete list of OIVD staff involved in standards activities is given in Appendix B.
|Laboratory Automation: Data Content for Specimen Identification, AUTO7-A||April 2005|
|Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems, LISI-A||April 2005|
|Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems, 2 nd Edition, LIS2-A2||April 2005|
|Standard Guide for Selection of a Clinical Laboratory Information Management System, LIS3-A||April 2005|
|Standard Guide for Documentation of Clinical Laboratory Computer Systems, LIS4-A||April 2005|
|Standard Specification for Transferring Clinical Observation Between Independent Computer Systems, LIS5-A||April 2005|
|Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems, LIS6-A||April 2005|
|Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory, LIS7-A||April 2005|
|Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems, LIS8-A||April 2005|
|Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures, LIS9-A||April 2005|