FDA Officials Concerned When Firms Don't Heed Good Consultant Advice
This article was originally published in The Silver Sheet
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...
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, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The proposed rule from the US HHS that would require its agencies to review all regulations every 10 years could distract an incoming Biden administration from the COVID-19 pandemic and will “wreak havoc” on Medicare, a senior policy analyst for the Center on Budget and Policy Priorities says.