Medical Device FDA Update and Pacific Region Discussion Topic… Importance of an Internal Quality System to the FDA

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 they maintain a level of service, inspection to insure the best protection of the public interest? Some obvious answers are to partner with supplying exporting countries but some not so obvious is put into practice the same level of systems they require 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 also take on the change to both to handle our eMDR and other e-submissions but also as a necessity to be much more efficient internally with ever pressing budget cuts.

As the medical device industry thrives and 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 the 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 a strong mission and vision to also make sure there is support for new technology and goods for the advancement of public health.
 
As it 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 their own internal FDA Quality System. Similar to any National or International Quality System standards, the FDA for the most part holds themselves to some of the same requirements and standards that are regulated onto the Medical Device industry and other Life Science, Food, and Drug industries they inspect.
 
This brief summarizes Mo’s presentation and outlines how the FDA drives their Quality System from Mission Statement and Vision to day-to-day operations. It 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. As the reader will see there are FDA priorities and investments toward comprehensive QMS that are expected to help achieve FDA goals and priorities within their specific mandate.
Get the full report here
 
http://www.expandable.com/landing/fda-regulatory-update-q2-2011.htm