Devicemakers Losing Time Responding to Increased FDA Enforcement Actions

As the FDA continues to ramp up its compliance and enforcement efforts, devicemakers are spending a lot more time dealing with the agency and answering a growing number of questions.

“We didn’t resource for it and that’s something we need to look at … what are we not doing when we’re taking time to answer FDA questions,” Patricia Shrader, senior vice president of corporate regulatory & external affairs at Becton Dickinson, said.

FDA staffers are calling companies more frequently to ask detailed questions about adverse events and recalls, Shrader said. Compounding the problem is that these calls are in addition to the monthly follow-up progress reports devicemakers are expected to routinely submit to the district office.
The GMP Letter