Medical Device & Diagnostic Industry

and balloon catheters manufactured by third parties outside the United States.

• Two postmarket studies completed during 2002–2005 and payments to medical personnel in connection with the studies.

• Compensation packages for some company staff.

Spectranetics said it is cooperating fully with the authorities.

CDRH
Enforcement
Actions Decline

CDRH enforcement actions declined significantly in fiscal year 2008, which ended Sept. 30. On Sept. 15, center director Daniel Schultz told the Regulatory Affairs Professionals Society’s (RAPS) annual meeting in Boston that there had been no device-related seizures, injunctions, or civil money

penalties for FY 2008, with data collected for 11 of the 12 months. This compares with four seizures, four injunctions, and one civil money penalty case in the previous year. And in FY 2006, CDRH was involved in four seizures and one civil money penalty, but no injunctions.

Device-related warning letters also were on a downward trend in FY 2008, with 134 being issued through Aug. 30, according to Schultz. In 2007, 155 warning letters were issued, and in 2006, there were 154. And recalls are on pace to be down about 11%, with 537 so far reported through Aug. 30, compared with 661 in 2007.

“Basically, we take the actions that need to be taken,” Schultz told RAPS. “We are not looking to take more actions, and we are not looking to take fewer actions. We are looking to take the right actions to be able to achieve compliance. We much prefer to do it through a well-placed warning letter or a well-placed FDA-483 and have those things fixed so we don’t have to go on

CDRH’S OTHER

PRIORITIES

Although developing an import safety strategy is CDRH’s top priority, the center’s other priorities include the following:

• Implementation of the center’s postmarket transformation, including successful integration of the matrix network into CDRH’s daily activities.

• Improved product access through continued implementation of the FDA Amendments Act of 2007 (FDAAA).

•Successful transition of all CDRH operations to the White Oak, MD, consolidated campus.

• Developing and implementing a knowledge-management strategy that maximizes the potential of every CDRH employee and advances every aspect of CDRH’s mission.