Medical Device & Diagnostic Industry

21%

24%

21%

13%

17%

4%

General Hospital

Opthalmic

Cardiovascular

Plastic Surgery

Restorative

Orthopedics

Figure 7. CDRH BIMO warning letters by

device category.

companies pursue the advancement of their technologies to the marketplace.

Lastly, we looked at specific device categories to assess whether certain device clinical studies tended to generate warning letters. In FY 2007, six categories of devices accounted for all warning letters issued by CDRH BIMO with cardiovascular, orthopedic, general hospital, and plastic surgery device studies topping the list (see Figure 7). FDA expected the data to be skewed in that direction because the

vast majority of active IDEs fall within the cardiovascular and orthopedic categories. In contrast, more than half of the device sponsors that received warning letters were associated with general hospital and plastic surgery devices.

Conclusion

What can we learn from a device GCP warning letter? Many device research entities view a warning letter as an opportunity for improvement. They incorporate the regulatory departures outlined in the warning letter into their CAPA program as part of their in-house quality system. This action promotes continuous quality improvement of research activities, which leads to higher-quality research data and enhanced human subject protection.

These outcomes may also lead to immediate and long-term dividends such as minimal clinical trial delays and un-planned costs, as well as reduced time to market—a win-win scenario for all parties involved. Additionally, CDRH has

seen some device firms use risk analysis principles to determine the likelihood of an unfortunate event occurring in their clinical trial processes. Firms then apply risk mitigation strategies to minimize its occurrence. Although this warning letter sample size is small, the information within this article may be helpful toward that end.

Acknowledgments

Special thanks go to CDRH’s Special Investigations Branch (Doreen Kezer, Catherine Parker, et al.) for their work in generating the CDRH BIMO data that formed the basis for this article.