H.R.3847 - Safety Of Untested and New Devices Act of 2012

To amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes. view all titles (3)

All Bill Titles

  • Official: To amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes. as introduced.
  • Short: Safety Of Untested and New Devices Act of 2012 as introduced.
  • Short: SOUND Devices Act of 2012 as introduced.

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Introduced
 
House
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President
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01/31/12
 
 
 
 
 
 
 

Official 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

Official 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. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order. Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor. Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device. Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal. Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device. Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.

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