H.R. 2426 · 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to…
Full title
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
ShimkusSponsorNo cosponsors.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R.
What it does: CRS summary · Introduced in House · May 19, 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)
Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 19, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.