On October 31, 2011, the Food and Drug Administration (FDA), Center for Device and Radiological Health (CDRH) released a report titled Understanding Barriers to Medical Device Quality (link to full report).  The initiative began in an effort to “assess and understand gaps in medical device quality” by gathering information through interviews with experts, internal and external, blinded industry interviews, a scan of databases, relevant articles, conferences and an outside press search.

The assessment discovered key facts about devices currently on the market along with areas for improvement in quality.  The key points from the reports show that the device industry has seen rapid growth in revenues and technical complexity over the last two decades, quality risks are not evenly distributed across the industry and failure in product design and manufacturing control caused over half of the recalls.  Recalls have increased, but the most noticeable increase is in adverse events when using devices.

The information from the companies who were interviewed by the FDA offered insight into how companies prioritize by putting compliance over quality in manufacturing.  Along with this problem, many companies see inconsistencies in application and interpretation between investigators and offices.  The goal of the FDA is to engage with the industry and provide transparency in reference to enforcement and increasing clarifications.