Medtech Insight 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


Centocor tumor marker reclassification petition to be approved "shortly" via FDA letter.

This article was originally published in The Gray Sheet

Executive Summary

SERUM TUMOR MARKER MOVE TO CLASS II WILL BE OUTLINED IN LETTER TO CENTOCOR which FDA plans to send "shortly," agency staffers say. Upon issuance of the letter, serum tumor markers will be considered Class II products and will go to market via 510(k), FDA says. A subsequent order in the Federal Register will formalize FDA's decision to downclassify serum tumor markets.



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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