3.0.0 1865 2020-02-10T17:06:49Z 2020-02-10T17:06:49Z Senate S S 2011-11-15 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-11-15T20:40:39Z 2011-11-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-11-15 Introduced in Senate IntroReferral 10000 9 Library of Congress F000457 Sen. Franken, Al [D-MN] Al Franken D MN N A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2011-11-15 True K000148 Sen. Kerry, John F. [D-MA] JOHN KERRY D MA FORBES 2011-11-15 True H001049 Sen. Hagan, Kay R. [D-NC] Kay Hagan D NC R. 2011-11-15 True Health Advisory bodies Child health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government ethics and transparency, public corruption Health technology, devices, supplies Medical ethics Medical tests and diagnostic methods Health 00 2011-11-15 Introduced in Senate 2012-03-27T22:02:01Z Patient Access to Medical Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to extend for five years and revise the program for humanitarian exemptions for pediatric medical devices. Removes provisions requiring the device to have been approved on or after September 27, 2007. Eliminates the authority of the Secretary of Health and Human Services (HHS) to establish an annual distribution number setting the maximum number of devices that could be distributed under the exemption. Sets such number as the number of devices needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. (Currently, this is the maximum number the Secretary may set.)

Eliminates the limitation on the number of waivers the Secretary may grant from conflict of interest provisions pertaining to service on an advisory committee. Requires the Secretary to ensure that each determination to waive such provisions considers the scope and magnitude of the financial interest at issue with the public health need for the expertise of the member on the committee.

]]> Patient Access to Medical Innovation Act Short Titles as Introduced Patient Access to Medical Innovation Act Display Title Patient Access to Medical Innovation Act Official Title as Introduced A bill to improve patient access to medical innovation. Introduced in Senate 2011-11-15T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1865is/xml/BILLS-112s1865is.xml 2011-11-15 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.