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Study: FDA Enforcement Actions against Device Manufacturers Increasing

Posted 18 January 2013 | By Alexander Gaffney, RAC

A study recently released by regulatory consulting group Greenleaf Health finds that enforcement actions taken by the US Food and Drug Administration (FDA)'s Center for Device and Radiological Health (CDRH) have been increasing steadily, leading to a potentially permanent shift that will have "long-lasting effects on regulated industry."

Those new enforcement actions are broadly targeted, the report notes, including the creation of its "Bad Ad" advertising review program, additional prosecutions for misdemeanor offenses and more warning letters.

The company's enforcement and compliance team, led by former FDA Association Commissioner for Regulatory Affairs Michael Chappell, reportedly looked at six sources of data for the study, with a particular emphasis on medical devices.

Those data sources: total FDA inspection, total inspections carried out by CDRH, the size of the companies inspected, the project areas inspected, observational decisions and which district office conducted the device inspection.

Those inspections, the report finds, are steadily on the rise. In 2005, for example, CDRH conducted 2,304 facility inspections. By 2011, it conducted 3,369 inspections-an increase of 46.2% in just six years.

FDA inspections as a whole during that time increased from approximately 16,000 to just under 25,000-an increase of more than 50%.

The good news, at least for some involved in regulatory affairs, is that these inspections aren't necessarily leading to more Form 483 inspection reports. The report notes that the issuance of 483s since 2006 has "remained steady over the five-year period" despite some small dips.

And while FDA warning letters as a whole exploded in 2011-other experts have noted this is in part due to FDA's new authority to issue warning letters for tobacco products-letters issued by CDRH have barely budged since 2005. In 2010, the agency issued 200 warning letters, or 29.7% of all FDA warning letters. It sent approximately 195 warning letters in 2011, or about 11% of all warning letters.

Recalls, meanwhile, represent a more complex picture. Whereas the agency issued about 1,500 recalls for regulated devices in 2004, it issued 3,211 in 2011-a more than 110% increase. With the exception of 2007 and 2009, every single year exhibited either an increase or a sustained number of recalls.

Read Greenleaf Health's study here.

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