Small Device Firms Often Unprepared for Bioresearch Monitoring

An increased number of violations coming from CDRH’s Bioresearch Monitoring program may indicate that the FDA is getting tougher when it comes to conducting device clinical trials. As a result, small device firms are being hit the hardest, Carl Anderson, senior consultant for Biologics Consulting Group, said. Because clinical trials for PMAs or 510(k)s rarely draw inspections, there is a smaller body of knowledge around compliance standards.

SOURCE: FDANEWS