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

FDA Officials Concerned When Firms Don't Heed Good Consultant Advice

This article was originally published in The Silver Sheet

Executive Summary

CONSULTANTS CAN HELP DEVICE MANUFACTURERS resolve quality systems problems, but companies don't always follow their consultants' recommendations, FDA officials lament. “The real challenge in working with these consultants and contractors ... is making sure [the recommendations] are sustainable and business-friendly,” says Bill Duffell, senior VP for global quality and regulatory affairs for Gambro Renal Products. The company recently got out from under an import ban imposed by FDA with the help of numerous consultants. “We got to a certain point on some things where we needed horsepower in addition to our own horsepower,” Duffell says. Meanwhile, an industry survey finds that manufacturers tend to pay anywhere from $100 to $250 per hour for independent quality and regulatory advice.

You may also be interested in...



Welch Allyn Regulatory Affairs Director On Consulting, Consultants

AS A FORMER CONSULTANT, WELCH ALLYN'S director of regulatory affairs has worked on both sides of the equation. He relates some common misperceptions in industry.

Device Week, 14 January 2021 – FDA Commissioner News; Spotlight On COVID-19 Enforcement Issues

On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.

FDA Issues 5-Point Action Plan For Artificial Intelligence/Machine Learning-Based SaMD

A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.

Topics

UsernamePublicRestriction

Register

LL016481

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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