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

UsernamePublicRestriction
UsernamePublicRestriction

HSV tests down-classified

This article was originally published in The Gray Sheet

Executive Summary

FDA 1proposed Jan. 9 to down-classify type 1 and 2 herpes simplex virus serological assays from Class III to Class II. More than 100 of the pre-amendment tests have been cleared under 510(k) applications since 1976, so there will be no practical difference in how the products are regulated once the reclassification goes through. The tests were assigned to Class III in 1982 because there was insufficient information about the herpes virus, an agency rep said...
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

MT023107

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

Cancel