Polsinelli - FDA Regulatory


May 2014


FDA Targets Medical Device Companies







FDA Regulatory Practice Leaders:


Melissa Gilmore




Peter Corsale





To learn more about our FDA Regulatory practice, or to contact one of our FDA Regulatory attorneys, click here.


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FDA Developing New Risk and Benefit Perception Scale

Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to continue through at least 2016.

Earlier this month, FDA released its 2012 medical device enforcement data, which evidenced:

  • A significant increase in the number of inspections.
  • A significant increase in the number of quality system warning letters issued.
  • A significant increase in foreign facility increase and disproportionate increase in quality system warning letters issued to foreign firms.

I. Quality System Inspections and Warning Letters on the Rise

In 2008, FDA conducted 2271 facility inspections. By 2012, that number had risen to 2748 – a 37 percent increase overall.

During those 2748 inspections of 2012, FDA made 4243 observations, the most common of which were:

  • Failures in corrective and preventative actions (CAPA) (i.e., regulations aimed at addressing complaints and nonconforming products), which was observed in 30% of the observations (1258 of 4243 observations) and
  • Inadequate production and process controls (P&PC), which was also observed in 30% of the observations (1303 of the 4243 observations).

While overall document control and retention observations were only found in 11% of all observations, the number of observations related to the maintenance of a device history record (a record that includes dates of manufacture, quantity of manufacture, quantity released, acceptance record, label, and control labels) increased significantly between 2011 and 2012 (173 observations to 190).

The increased number of inspections led to an unsurprising increase in the number of warning letters issued:

  • 2012: 164 warning letters
  • 2011: 122 warning letters
  • 2010: 89 warning letters
  • 2009: 77 warning letters

The most frequent warning letter violations centered on CAPA violations (32% of all warning letters) and P&PC violations (30% of all violations). Similarly, there was a noticeable increase in warning letters related to design history document retention issues (51 warning letters). Also noted by the FDA was an increase warning letters related to P&PC-related process validation violations (49 warning letters).

II. Foreign Facilities Are Taken to Task

While overall numbers showed a rise of routine quality system surveillance inspections of 37 percent, foreign facilities alone experienced a 93 percent increase, and a disproportionate amount of violations. That is, while foreign firms accounted for 300 of the 2748 inspections (10%), they accounted for 66 of the 164 warning letters (40%).

FDA attributes this fact to not only increased focus, but improved site selection, with enforcement spread equally between Europe and Asia:

  • Approximately one third of the warning letters issued to foreign facilities were directed at Chinese firms (20 of 66).
  • Another third were directed at European facilities (Germany-9; Italy-6; UK-6; and Denmark-3).
  • The remaining warning letters were issued to Japanese (3), Taiwanese (3), and Canadian (2) establishments.

Please contact the authors freely should you have any questions or would like assistance with FDA inspections, 483s, or warning letters.

For More Information

For more information about the contents of this eAlert, please contact the authors:











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*Law360, March 2014






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