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