A Medical Device Daily

The FDA’s Center for Devices and Radiological Health (CDRH) has posted on its web site its Annual Report for 2006, not unexpectedly rather self-congratulatory — underlining what it considers to be its major accomplishments for the year.

Following are some highlights from the report, cited in a cover letter by the center’s director Daniel Schultz:

• The center estimates that it monitors nearly 100,000 medical products.

• It says that it produced “a comprehensive report on the Postmarket Device Safety Program” and that a “senior level Postmarket Transformation Leadership Team met throughout FY 2006 to evaluate the recommendations and propose a plan for a transformed postmarket program.”

• The center “has met or is on track to meet most goals for FYs 2003-2006.” It issued “six MDUFMA guidance documents; held two MDUFMA stakeholders meetings; issued 14 Federal Register notices and three reports to Congress; and granted 698 Small Business Determinations — an 8% increase over FY 2005.”

• The center in 2006 received 200,000 adverse event reports concerning medical devices.

• It classified 651 recall actions involving 1,550 products and took 55 enforcement actions.

• The center “exceeded FY 2006 inspection goals by at least 20% for domestic, foreign, and bioresearch monitoring inspections.

• The center conducted annual inspections at over 8,000 mamography facilities, and ensured “that 98% met inspection standards with less than 2% having Level I (serious) problems.”

• The center enhanced its information technology systems “to facilitate submissions, expedite reviews, and simplify tracking of device thorughout the product life cycle.

• It developed an employee orientation program for improving training. It said that a “competency development program was another hallmark of FY 2006.”

The cover letter highlights three technologies either cleared or approved:

• a CLIA waiver for a rapid blood lead test system: the LeadCare II Blood Lead Test from ESA Biosciences, a subsidiary of Magellan Biosciences (both Chelmsford, Massachusetts) (Medical Device Daily, July 27, 2006/Sept. 21, 2006);

• a continuous glucose monitoring system that detects blood glucose trends and tracks pattenrs for diabetic patients, the DexCom STS Continuous Glucose Monitoring System by DexCom (San Diego) (MDD, April 4, 2006);

• and a device that provides an alternative to open heart surgery for pediatric and young adult patients, the Helex Septal Occluder from W.L. Gore & Associates (Gore: Flagstaff, Arizona), initially launched outside the U.S. in 2001 (MDD, May 30, 2001).

No Comments