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U.S. Department of Health and Human Services

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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 dsmica@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307).

Document Name Office/Division Date
Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CDRH CBER 11/30/2004
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry OIVD / DCTD 12/24/2004
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems OIVD / DCTD 3/10/2005
Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System OIVD / DCTD 3/10/2005
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Automated Fluorescence insitu Hybridization (FISH) Enumeration Systems OIVD / DIHD 3/23/2005
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing) OIVD / DIHD 8/25/2005
Draft Guidance for Industry and FDA Staff - Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications OIVD 9/7/2005
Guidance for Industry - Review Criteria for Assessment of C‑Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays OIVD / DCTD 9/22/2005

Standards Recognized

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.

Title Date Recognized
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
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