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

In Brief: FDA's HACCP concept

This article was originally published in The Gray Sheet

Executive Summary

FDA's HACCP concept: Agency proposal to implement a new inspection methodology based on hazard analysis critical control points is rejected by industry representatives at a Nov. 20 FDA/industry meeting in Washington, D.C. As proposed at the meeting, the program would have directed inspectors to examine critical points in the manufacturing process that would be more likely to result in device failures if deficient ("The Gray Sheet" May 19, p. 6). Reps from the Health Industry Manufacturers Association, the National Electrical Manufacturers Association and the Association of Medical Diagnostics Manufacturers dismissed the concept as being incompatible with quality system regulations, pointing out that too many device manufacturing procedures would constitute critical control points. The trade groups resolved to form a working group with FDA to examine different ways of reviewing FDA's compliance program guide with the aim of shortening inspections for all devices. The group's initial meeting is scheduled for January...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT009221

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