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

Mayo Clinic IDE violations due to misinterpretation of custom device regs.

This article was originally published in The Gray Sheet

Executive Summary

MAYO CLINIC "MISINTERPRETATION" OF CUSTOM DEVICE DEFINITION resulted in violations of FDA investigation device regulations cited by FDA in an Oct. 23 FDA warning letter to the clinic. In the letter, FDA says that Rochester, Minnesota-based Mayo Clinic failed to obtain the necessary investigational device exemption and investigational review board approval for its study of an artificial hip implant.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT007109

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