The evolution of medical device regulation in the United States

By Manish K. Sethi, MD; Hassan R. Mir, MD; William T. Obremskey, MD, MPH; and A. Alex Jahangir, MD

The IOM, the FDA, and the 510(k) process

On Sept. 23, 2009, the U.S. Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to study the premarket notification program—known as the 510(k) process—used to review and clear most medical devices marketed in the United States. After nearly 2 years of study, the IOM finally released its findings on July 29, 2011.

This content is only available to members of the AAOS.

Please log in using the link at the top right corner of this page to access your exclusive AAOS member content.

Not a member? Become a member!