Medical Device & Diagnostic Industry

research misconduct and previously violative inspections. The majority of SIB-related warning letters were the result of research misconduct complaints. Other warning letters issued were related to repeat offenders and other surveillance inspections.

BIMO’s Program Enforcement Branch issued nine warning letters, due primarily to CDRH’s early intervention and marketing application activities. Early intervention activities

research entities with previously violative inspections tend to be repeat offenders. On the other hand, CDRH issued 77% of the warning letters to sites that FDA inspected for the first time (see Figure 5). In most cases, systemic issues such as lack of GCP training, lack of management or supervisory oversight, and ineffective corrective and preventive actions were

the primary causes of warning letter issuance.

Warning Letter Response

When a regulated entity receives a warning letter, the recipient must provide a response within 15 days of receipt. In some cases, CDRH BIMO grants extensions in order for the regulated entity to provide its clear and

Research entities with

previously violative

inspections tend to be

repeat offenders.

are risk based and focus on active IDE studies of novel technologies, vulnerable populations, or significant public health issues. It is interesting to note that CDRH BIMO inspections conducted pursuant to marketing applications (i.e., PMA, 510(k), etc.) resulted in the issuance of just two warning letters in FY 2007, none of which generated data reliability concerns. One explanation is that BIMO’s early intervention program sensitizes device firms to the importance of well-managed clinical trials during the active research phase, leading to marketing applications with higher-quality studies.

CDRH BIMO issued 23% of the warning letters to sites that had a previous BIMO inspection. Of the seven sites that had a previous BIMO inspection, nearly three-quarters of those sites had a previously violative inspection (i.e., had received at least a warning letter). Based on this information,