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Will FDA changes influence healthcare packaging?

Dr. Michael Drues, president of Vascular Sciences, offers a perspective on the state of the FDA, the 510(k), and labeling issues.

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Packaging World:
With a new political administration, a new commissioner in Margaret Hamburg, and a host of issues to tackle, the U.S. FDA has its share of challenges, doesn’t it?

Dr. Michael Drues:
The FDA has been under a tremendous amount of scrutiny for the last few years, and will continue to be. It’s unfortunate that so many in our industry view the FDA as nothing more than an obstacle or hurdle to get over in order to get their product to the market. The FDA has an awesome responsibility. Yes, it can be bureaucratic and inefficient. But nonetheless, it has a difficult job. So feel free to call the agency and ask them questions. In particular, go to www.fda.gov and search for the Division of Small Manufacturers, International and Consumer Assistance (DSMICA). The site provides contact names for assistance on a variety of issues, including 510(k) submissions, inspections, labeling, regulations, etc.

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