H.R.3847: SOUND Devices Act of 2012

About This Bill

  • This bill was introduced in the 112th Congress
  • This bill is primarily about health
  • Introduced Jan. 31, 2012
  • Latest Major Action Jan. 31, 2012

Bill Summary

Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws....

(Source: Library of Congress)

Bill Actions

Date Description
Referred to the House Committee on Energy and Commerce.
Jan. 31, 2012

Introduced in the House by Edward J. Markey (D-Mass.)

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