January 1, 2012

Tension in the medical device industry is building as the industry continues to speculate about what the FDA will unveil regarding changes to its premarket notification submission process, otherwise known as the 510(k) process. For years, the 510(k) process has been under intense scrutiny by the Senate and House, as well as by critics within the FDA, and last summer’s recommendation from the Institute of Medicine to simply scrap the process altogether sent shockwaves through the industry.

One thing is certain: changes are coming. In her article, Medical Device Regulations: The Shape of Things to Come, published by LES Insights, NAI Senior Consultant Jill Sackman, D.V.M., Ph.D., offers a preview of what these changes are likely to entail, and what their implications will be for medical device companies.