FDA ombud: Industry complaints up 45 percent in 2009

April 8, 2010 by MassDevice staff

The Food & Drug Administration's Center for Devices & Radiological Health received a record number of calls from the medical device industry last year, according to a report from the federal watchdog agency's ombudsman.

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The Food & Drug Administration's Center for Devices and Radiological Health saw a dramatic, 45 percent increase in complaints last year, logging a record high of 133 in 2009.

In total, the agency received 250 contacts during the year, a 41 percent increase from the previous high-water mark of 177 in 2007, according to the agency's annual ombudsman's report. The 2009 tally is also a record high for the agency, which first opened its ombudsman office in 2000.

The complaints, made primarily by industry, seemed to center on the agency's Office of Device Evaluation, which accounted for about 54 percent of the contacts. The FDA's compliance office came in a distant second, logging about 17 percent of total complaints.

Not surprisingly, the most complaints revolved around the watchdog's embattled 510(k) program, which accounted for 17 percent of all complaints. Some of the beefs listed by industry included data/testing requirements and lack of timeliness. There were also complaints about CDRH employees and various policies and procedures.

  2009 2008 2007 2006 2005 2004 2003 2002 2001
Calls 250 170 177 120 114 125 120 53 72
Complaints 133 92 85 56 72 77 82 27 51
Disputes 53 31 55 40 25 39 38 26 21

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