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

REAGENTS GUIDANCE EASES 510(k) RULES FOR OEM REAGENTS USED WITH MODIFIED ANALYZERS, SECONDARY REAGENTS FOR MULTIPLE SYSTEMS; EFFECTIVE DATE JUNE 17

This article was originally published in The Gray Sheet

Executive Summary

Premarket notification submission requirements for many in vitro diagnostic reagent manufacturers will be considerably reduced under an FDA guidance that goes into effect June 17. The document, called "Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers," was released June 10.
UsernamePublicRestriction

Register

MT006191

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