Experts: CDRH Needs Inspectors With More Experience, Training

The quality of device inspections is suffering because of CDRH’s lack of trained, experienced investigators. CDRH has struggled to find funding to train investigators beyond the basic device regulatory requirements, Edwin Bills, a compliance expert at Bilanx Consulting, said. The retirement or reassignment of more experienced investigators also has had an impact on device inspections, Benjamin England, a former FDA device investigator, said.
Devices & Diagnostics Letter