US Congress House Bill 3847 (Prior Session Legislation)

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January 31 2012 - Referred to the House Committee on Energy and Commerce.
Pending: House Energy And Commerce Committee
Text: Latest bill text (Introduced) [PDF]

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.

Safety Of Untested and New Devices Act of 2012

Rep Markey, Edward J.	Rep DeLauro, Rosa L.	Rep Schakowsky, Janice D.	Rep Slaughter, Louise McIntosh
Rep Waxman, Henry A.

Date	Chamber	Action
2012-01-31	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	http://thomas.loc.gov/cgi-bin/bdquery/z?d112:HN03847:@@@L&summ2=m&
Text	http://gpo.gov/fdsys/pkg/BILLS-112hr3847ih/pdf/BILLS-112hr3847ih.pdf