FDA, Industry Grapple with Similar Quality, Technology Challenges

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Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

With the explosive growth in imported goods to the US and very tight budgets to maintain a level of public safety, what is the FDA doing to insure it maintains a level of service inspection to insure the best protection of the public health? Some obvious answers are to partner with supplying exporting countries but another, perhaps less obvious one is to demand of itself the same level of systems it requires of the medical device industry and other industry segments they oversee. While the FDA pushes even harder on the medical device and lifescience industry toward electronic reporting to the FDA, internally they must not only tackle the challenge to how to handle eMDR and other e-submissions, but also to be much more efficient internally with ever pressing budget cuts.

Electronic Submissions to FDA

As the medical device industry grows, the FDA continues its 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 current regulatory thinking.

As medical device industry leaders, we know the attention to detail that is required in setting up a validated, comprehensive and business workable quality system in compliance with FDA regulation. While the FDA’s mandate of safe products in the US marketplace is paramount, there is also a strong mission and vision to make sure there is support for new technology and goods for the advancement of public health.

Turns out the FDA faces some of the same challenges all medical device companies face – how to do more with less while ensuring a level of world-class excellence in an ever-growing global economic supply chain.

In this quarter’s FDA update (Q2, 2011), Mo Samimi of the FDA presents some of the details behind the FDA in defining, setting up, implementing and managing its own internal FDA quality system. Similar to any national or international quality system standards, the FDA for the most part holds itself to some of the same requirements and standards that are required of the medical device industry and other life science, food, and drug industries they regulate.

Mo outlines how the FDA drives their quality system from mission statement and vision to day-to-day operations. He also shows how some of these same goals align with companies that are positioning themselves to become world suppliers of regulated goods with limited resources that must become more efficient over time.

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