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

Apotex Seeking FDA Reconsideration Of Normocarb Drug Designation

This article was originally published in The Gray Sheet

Executive Summary

Apotex wants FDA to designate its Normocarb pre-filter hemofiltration solution as a device instead of a drug in the hope that it can be cleared through the 510(k) process

You may also be interested in...



Congressional Inquiry Into FDA Combo Product Policy Needed – Consultant

R. Sheridan Consulting is urging Congress to review FDA's criteria for determining whether a combination product should be regulated as a drug or a device

ASTM Developing Standard To Tackle Dried Blood On Steel Devices

ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.

UsernamePublicRestriction

Register

OM001644

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

Cancel