S. 1700 · 112th Congress
Medical Device Regulatory Improvement Act
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
KlobucharSponsor3 cosponsors · 1 D, 2 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety…
What it does: CRS summary · Introduced in Senate · Oct 13, 2011
Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness; (2) consider alternative approaches to evaluating device safety and effectiveness; (3) use all reasonable mechanisms to lessen review times and render regulatory decisions; (4) determine whether pre-clinical data can meet the statutory threshold for approval; and (5) utilize, whenever practicable, alternatives to randomized, controlled clinical trials if clinical data are needed.
Requires the Secretary, in determining the least burdensome means of determining substantial equivalence, to: (1) focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device, (2) not request or accept information unrelated or irrelevant to the substantial equivalence evaluation, (3) review the labeling of the device to assess the intended use of the device and not evaluate issues that do not present a major impact on the intended use as set forth in the labeling, (4) consider alternative approaches to evaluating substantial equivalence, and (5) use all reasonable mechanisms to lessen review times and render regulatory decisions.
Repeals conflict-of-interest provisions that are specific to the Food and Drug Administration (FDA) and provides for the continued applicability of conflict-of-interest provisions otherwise applicable to advisory committees, federal employees, and special government employees.
Requires the Secretary to contract with an eligible entity for a review of the management and regulatory processes at the Center for Devices and Radiological Health.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Medical Device Regulatory Improvement Act
Latest action (Oct 13, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Oct 13, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.