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

Cyberonics Hits A Nerve: FDA Issues Firm Warning Letter For QSR Deficiencies

This article was originally published in The Gray Sheet

Executive Summary

FDA's warning letter citing Cyberonics for quality system regulation lapses presents a further challenge for the device company as it seeks approval for a depression indication

You may also be interested in...



Cyberonics Depression Approval Contingent On Dosing Trial, Registry

Cyberonics will start a 450-patient, three-year dosing trial in order to gain PMA approval for its VNS Therapy neuromodulation device for use in treatment-resistant depression patients

Cyberonics Depression Approval Contingent On Dosing Trial, Registry

Cyberonics will start a 450-patient, three-year dosing trial in order to gain PMA approval for its VNS Therapy neuromodulation device for use in treatment-resistant depression patients

Cyberonics answers FDA

Neurostim firm submits response Jan. 21 to FDA's December warning letter, asserting that compliance with good manufacturing practice requirements has been established. In a same-day release, CEO Skip Cummins says that "the response also identified the corrective actions already implemented since the beginning of the inspection and the corrective actions Cyberonics will implement in the coming months" (1"The Gray Sheet" Jan. 10, 2005, p. 14). The firm reiterates it expects FDA approval for its VNS Therapy depression indication by the end of January...

Related Content

UsernamePublicRestriction

Register

MT021407

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