3.0.0 1700 2023-01-11T13:21:59Z 2023-01-11T13:21:59Z Senate S S 2011-10-13 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-10-13T16:32:18Z 2011-10-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-10-13 Introduced in Senate IntroReferral 10000 9 Library of Congress K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2011-10-13 True B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2011-10-13 True C000560 Sen. Coburn, Tom [R-OK] TOM COBURN R OK 2012-03-22 False Health Advisory bodies Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government ethics and transparency, public corruption Government studies and investigations Health technology, devices, supplies Health 00 2011-10-13 Introduced in Senate 2012-01-27T23:20:51Z 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.

]]> Medical Device Regulatory Improvement Act Display Title Medical Device Regulatory Improvement Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to device review determinations and conflicts of interest, and for other purposes. Introduced in Senate IS Short Titles as Introduced Medical Device Regulatory Improvement Act Introduced in Senate 2011-10-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1700is/xml/BILLS-112s1700is.xml 2011-10-13 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.