H.R.3211 - Humanitarian Device Reform Act of 2011112th Congress (2011-2012)
Summary: H.R.3211 — 112th Congress (2011-2012)
Introduced in House (10/14/2011)
Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.