In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Gray Sheet

Executive Summary

The Centers for Disease Control and Prevention currently is informally assisting FDA in determining complexity categorizations under the Clinical Laboratory Improvements Amendments of 1988 for new in vitro tests and also is sending out notification letters to manufacturers. CDC was to take on sole responsibility from FDA for the categorizations on Sept. 1, but the Office of Management and Budget raised concerns with the switch ("The Gray Sheet" Sept. 12, p. 5). CDC is helping to eliminate the backlog of tests needing categorization in preparation for its possible assumption of the responsibilities. HHS also is still working out how to address the problem of FDA's inability to undertake its CLIA quality control labeling review responsibilities due to a lack of resources. The Health Care Financing Administration is expected to publish a notice extending the Sept. 1 deadline by which all in vitro test labeling was supposed to conform with CLIA QC requirements; HCFA has said it will not enforce the requirements before the extension is published



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts