HR 3211
112th Congress
House
Health
Administrative remedies
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Health technology, devices, supplies
Humanitarian Device Reform Act of 2011
Introduced: October 14, 2011
See on congress.gov
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
Plain-English summary
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.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
2