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

HAEMONETICS MCS APHERESIS SYSTEM PROMOTION FOR UNAPPROVED USE

This article was originally published in The Gray Sheet

Executive Summary

HAEMONETICS MCS APHERESIS SYSTEM PROMOTION FOR UNAPPROVED USE is cited in a March 16 warning letter to the firm. The MCS mobile collection apheresis system, which is 510(k) cleared for platelet apheresis, is being promoted "for purposes for which it was never officially cleared and/or approved in violation of the Food, Drug and Cosmetic Act," FDA alleges. "Continued promotion, either written or verbal, could result in regulatory action without further notice," FDA warns.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT002112

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