FDA, Industry Grapple with Similar Quality, Technology Challenges

FDA is making an effort to keep industry informed of its thinking

Published: Monday, June 27, 2011 - 05:00

With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner with the countries exporting the supplies. Perhaps a less obvious option is for the FDA to demand of itself the same level of regulatory compliance and reporting that it requires of the medical device industry and other industry segments.

As the FDA pushes even harder on the medical device and life sciences industries toward electronic reporting to the administration, the FDA must rise to the challenge of handling the increasing volume of electronic medical device reports (eMDR) and other electronic submissions while facing more budget cuts.

Figure 1: Total electronic submissions to FDA (all centers)

As the medical device industry grows, the FDA continues its effort to connect with the manufacturers and provide updates and to open an avenue of two-way communication in sharing current regulatory thinking.

Medical device industry leaders know the attention to detail that is required in setting up a validated, comprehensive, and business-workable quality system in compliance with FDA regulations. While the FDA’s mandate of safe products in the U.S. marketplace is paramount, there is also a strong mission to assure support for new technology and goods for the advancement of public health.

The FDA is facing 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 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.

Samimi outlines how the FDA drives its 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.

A summary of the Q2-2011 quarterly update is available here.

About The Author

Dennis Payton

Dennis Payton is the executive director of product marketing at Expandable Software Inc. which develops, markets, and supports its enterprise resource planning (ERP) manufacturing software suite designed to help expanding manufacturers manage their long-term growth.