News and Insights
NAI Published in Medtech Executive on Changes to the 510(K) Process
December 1, 2011
The Institute of Medicine’s recent recommendation that the FDA should scrap the 510(k) process earlier this year sent shockwaves through the medical device industry. While the FDA has announced that it does not intend to end this approval process, device companies must expect additional, significant changes to the 510(k) process and post-market safety requirements.
In 510(k) Clearance — Change Is in the Wind, published by MX: Medtech Executive, NAI Consultant Stephen Rothenberg, J.D. and Senior Consultant Jill Sackman, Ph.D., D.V.M. explain what these changes are likely to entail, and how medical device companies should prepare.