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

Class I Recalls Break Record; FDA Begins Product-Specific Inquiries

This article was originally published in The Silver Sheet

Executive Summary

RECALLS OF MEDICAL DEVICES REACHED A RECORD LEVEL IN 2004, with 612 actions reported. A dramatic rise in Class I recalls has prompted FDA’s device center to look more closely at worrisome trends in certain product areas, including in vitro diagnostics. A new agency requirement for press releases on all Class I recalls should please consumers and members of Congress demanding greater openness from FDA, but a leading IVD industry spokeswoman questions the policy’s value to public health. Recent enforcement actions are a reminder that Class I recalls almost invariably lead to FDA scrutiny of a firm’s quality system

Topics

UsernamePublicRestriction

Register

MT036097

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