Medical Device FDA Update and Pacific Region Discussion Topic: Regulating Medical Device Software

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As the medical device industry thrives and grows, the FDA is making an effort to reach out to industry manufacturers to provide updates, allow the agency to be better connected, and to open an avenue of two way communication in sharing the current regulatory thinking.

In the Pacific Region, the leadership is looking to have regular quarterly sessions in a town hall style format to provide how the medical device manufactures are performing, discuss relevant current market technologies, how the FDA will treat these new technologies from a public safety interpretation of Food, Drug and Cosmetic Act (FD&C), and the enforcement of resulting regulation.

2004 - 2009: CDRH Inspections, Observations and Warning Letters

This quarter’s FDA Pacific Regional Medical Device Update hosted by ASQ‘s Northern California Biomedical Discussion Group in March, showed medical device inspections in 2009 trending lower in the issuance of 483 observations and warning letters, while medical device manufacturing inspections remained constant. This sounds like great news but what about the 2010 results? Will they continue this trend or is the medical device industry headed for a blip in the chart? We’re still waiting for FDA’s final compilations of numbers.

One of the growing hot topics for medical devices is the application of software to the medical diagnostics, therapy, treatment, control of medical systems, etc., and how software as viewed by the FDA with respect to regulation definition, requirements and enforcement. An overview discussion on the topic of medical device software was a primary focal point for this quarter’s discussion and some very good guidance is available for medical device manufacturers and standalone medical device software products. You’d be surprised that one of the biggest concerns and where issue arises is in having very tight quality control processes over your software suppliers.

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