FDA Globalization Act - Coming Soon

The FDA Globalization Act was introduced in Congress this month by Congressman John Dingell. If passed, the Act will have several implications for medical device manufacturers. Among them: 1) manufacturers will be assessed a registration fee when registering their manufacturing facilities, the funds will help pay for many new federal requirements, 2) manufacturing sites will be inspected immediately upon receipt of the registration fee, 3) the plant will be inspected again when the establishmet begins to manufacture, 4) no Class II or Class III device may be imported before initial inspection, 5) device labeling must indicate the country of manufacture, 6) commercial importers will be required to register and pay a fee, 7) manufacturing sites will be issued a unique identification number following registration, and the registration ID number may be used for other purposes, and finally 8) the Secretary shall establish and maintain a corps of inspectors dedication to inspection of foreign manufacturing sites.

I applaud the requirements, both as a consumer and as a consultant. As a consultant I have seen, first hand, some of the poorly manufactured products that are imported from certain foreign manufacturers. And as a consumer I have worried for my family's health. 

Global trade has been good for me and my consulting business. It has brought in foreign Clients. It has exposed me to other ways of thinking. It has given me an opportunity to travel the world in a way that I would not have been able to otherwise. But globalization has come at a cost, and one cost has been the safety of our own medical products. This is unacceptable because, ultimately, it is a direct threat to me.

FDA has been weakened under the Bush administration, it has too few inspectors and reviewers and is losing its most experienced people. That is a loss for all of us and it is time FDA be strengthened and reinforced.   

Here is the link, in case you want to read the draft Act for yourself:
http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf