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

FDA Limited In Its Ability To Prevent Unsafe Device Designs

This article was originally published in The Silver Sheet

Executive Summary

ENSURING USER-FRIENDLY DEVICE DESIGN is not always easy for FDA, especially when it comes to products approved through the 510(k) process. Brushing up against some of the gray areas in premarket review laws, agency reps explain their thinking, practices – and questions – on the topic of device usability. Human factors experts say industry has come a long way toward improving device designs to reduce the potential for use errors and resultant patient injuries and deaths. Nevertheless, recalls and adverse event reports suggest more could be done. Abbott and Medrad describe their human factors engineering efforts
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036093

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