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Letter to Quest Diagnostics
Certified Mail March 2, 2004 Mr. Kenneth W. Freeman Dear Mr. Freeman: The Office of In Vitro Diagnostic Devices (OIVD) and the Centers for Medicare and Medicaid Services (CMS) have reviewed reports indicating that Quest is offering, or will soon offer, a test for early-stage ovarian cancer, based on technology licensed from Correlogic Systems, Inc. Because the nature of this test is not clear from the materials we have reviewed, we are uncertain if your ovarian cancer offering will be subject to regulation only by CMS, under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), or whether it may also require premarket review by FDA under the Federal Food, Drug, and Cosmetic Act. We invite you to meet with me and Ms. Judy Yost, Director of the Division of Laboratory Services at CMS at your earliest convenience to discuss the nature and appropriate regulatory status of the technology. You may schedule this visit for Washington through my office (301-594-3084) or for Baltimore through Ms. Yost’s office (410-786-3531). We are committed to working with you as we strive to protect the public health without unnecessarily imposing regulatory burdens on the marketing of products of potential clinical importance.
Page updated March 5, 2004 |
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