New Developments in FDA's Oversight of Waived Tests: What Is the Impact on the Lab Industry?

With the release of its recent guidance, the FDA has updated its approach to waived testing, a change that will impact many of the over 122,000 labs and 55,000 physician office labs in the U.S. that have a certificate of waiver under CLIA.

While the FDA defines waived tests as "simple" and having "an insignificant risk of an erroneous result", some in the industry have expressed concern over the safety of non-laboratory personnel performing any type of diagnostic test. In addition, manufacturers of the tests have complained that the waiver application’s accuracy and erroneous result studies are illogical and burdensome.

Join Washington G-2 Reports as experts from the FDA detail the key changes in this new guidance, and hear reactions on the guidance from a leader in the clinical laboratory industry. This intensive 90-minute program will bring you up-to-date on these important regulatory developments, whether you are an IVD manufacturer or work in a laboratory performing waived tests.

During this audioconference, you will learn:

Learn about the growing number & type of waived tests and how this trend is changing the clinical laboratory industry
Understand the thinking of FDA in its recently released waived testing guidance
Find out how the guidance changes the oversight of waived tests & its impact on the lab market
Assess how FDA's approach will affect certificate-of-waiver labs
Identify specific industry concerns surrounding the way FDA is handling waived testing

You’ll also have the opportunity to ask questions in our interactive Q&A portion of the program. Take this hassle-free approach to learn about these important developments in a growing area of the IVD market. You can invite your entire staff—for one low fee.

FEATURED FACULTY

Carol Benson
Associate Director, Division of Chemistry and Toxicology Devices, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)

Carol C. Benson, M.A., is an associate director in the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety. Ms. Benson has a BS degree in Medical Technology and a MA in Health Care Administration. She has been with FDA for the past 14 years. Prior to coming to the FDA, she worked at the NIH Clinical Chemistry Laboratory as a QC supervisor and Laboratory Manager. At FDA she assigns incoming work, signs off completed work for the branch and participates in writing guidances, and in the review of CLIA waiver applications.

Marina V. Kondratovich, Ph.D.
Statistician, Division of Biostatistics, CDRH, FDA

Marina V. Kondratovich, Ph.D., is a mathematical statistician for the Center for Devices and Radiological Health, Division of Biostatistics, U.S. Food and Drug Administration. Dr. Kondratovich graduated with a Ph.D. in Mathematical Statistics from the Department of Statistical Modeling at St. Petersburg University in Russia. She taught statistics at universities in both Russia and the Ukraine.

She joined the FDA’s Center for Devices and Radiological Health as a mathematical statistician 8 years ago. As a member of the Diagnostic Devices branch, she performs statistical review of submissions for diagnostic devices. She has been FDA spokesperson for statistics at multiple FDA Advisory Panel meetings and at meetings with medical devices manufacturers. Dr. Kondratovich is an active member of Clinical Laboratory Standard Institute (CLSI) and International Standardization Organization (ISO). She is actively involved in the different activities of the FDA CLIA program from the beginning of this program in the FDA.

Elissa Passiment
Executive Vice President

Elissa Passiment is the Executive Vice President of the American Society for Clinical Laboratory Science (ASCLS). She is a clinical laboratory scientist with over twenty years experience in clinical laboratories as staff, educator and manager. Elissa came to ASCLS after six years in health care consulting with an international health care firm. During her consulting tenure, she and her staff conducted studies and redesigned the work and facilities for hospitals in the United States and Canada. In that process, she also conducted workshops and discussion groups to facilitate the changes the client was being asked to implement.

HOST & MODERATOR:

Julie McDowell
Managing Editor, Laboratory Industry Report, Washington G2 Reports

For more information, please call 800-401-5937, ext. 2.

Continuing education credit is available.