Medtech Insight is part of the Business Intelligence Division 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

Warning Letter Roundup & Recap – September 1, 2015

This article was originally published in The Gray Sheet

Executive Summary

Cardiac monitor manufacturer Cardiac Designs didn't have an adequate system for receiving and evaluating complaints forwarded to the firm from a third-party complaint handling company; marketer of the WaveLight EX500 Excimer Laser System – used in LASIK procedures – was cited for premarket reg violations; and more. Four device warning letters were listed by FDA this week.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT034181

Ask The Analyst

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

All set! This Question has been sent to 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