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.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.