Originally Published MDDI May 2004

EDITOR'S PAGE

The center under David Feigal did a good job of keeping up with changes in laws and technologies. His successor will need to exceed those accomplishments.

Departing CDRH director David Feigal leaves a lasting mark on the agency.

David Feigal's five-year tenure as CDRH director was eventful and productive. At the end of his service, Feigal left a much different center than the one established in 1999. But for the most part, CDRH has adapted to these changes.

Feigal has drawn much praise from industry for how he managed the center through such a transformation. It is essential that his successor continue to manage those changes well. But 
the new director may also need to make further adaptations to keep up with the breakneck pace of new medical technology development. (For a report on Feigal's departure, see NewsTrends, p. 32).

Thanks to Feigal and his team, the reforms mandated by the FDA Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) have been set in motion without too many false starts. Feigal pulled no punches in alerting Washington's powers-that-be to CDRH's plight. He argued forcefully and eloquently that it did not have an adequate budget to review applications and inspect facilities as efficiently and effectively as needed. 

And now alternative resources are in place. The third-party review and inspection programs enable others to handle low-risk applications and inspections so CDRH can concentrate on the high-risk ones. More reliance on outside experts has enabled the center to better evaluate the most cutting-edge technologies.

More use of continuing-education programs for CDRH staff has made them better able to keep up with the latest technologies. Better collaboration with other FDA centers has allowed breakthrough combination products to come to market in a timely fashion. And of course, the new user-fee system has given CDRH's review teams more resources than they've had in years. Feigal's successor needs to ensure that these new systems continue to function, and that others are implemented as necessary. That means the next director must have a keen understanding of the device industry and the direction in which it is heading. 

“This is a critical juncture for CDRH,” said Elizabeth Jacobson, AdvaMed's executive vice president for technology and regulatory affairs. “There is uncertainty about congressional appropriations and the need to keep user fees from having huge increases.”

Mark Leahey, executive director of the Medical Device Manufacturers Association, pointed out that the new CDRH chief must be aware of the unique ways in which the device industry develops products. With much of the innovation coming from smaller companies, understanding their needs is essential to ensuring that the industry continues to make crucial new medical technologies available to the public.

FDA should make sure that Feigal's successor has these qualities:

• Strong leadership and management skills.
• Strong communication skills, including the ability to relate to junior reviewers and inspectors.
• A willingness to take input from industry. That means considering its perspective as much as that of any other stakeholder.
• An understanding of how device technology is progressing and of who can help CDRH keep pace with it. New developments will raise challenges that the CDRH staff has yet to face.
• A willingness to try creative solutions should existing policies fail. For example, if user fees continue to rise 35% per year, the program may not be sustainable. Adjustments to the program might be warranted.
• An understanding that industry and CDRH have the same goal—to get safe and effective medical devices to those who need them.

The Editors

Copyright ©2004 Medical Device & Diagnostic Industry