3.0.0 2188 2023-01-11T13:29:31Z 2023-01-11T13:29:31Z Senate S 2015-10-21 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-10-21T18:03:10Z To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. 114 2428 HR 2015-05-22 Referred to the Subcommittee on Health. Related bill CRS 21st Century Cures Act 114 6 HR 2015-07-13 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 21st Century Cures Act 114 34 HR 2016-12-13 Became Public Law No: 114-255. Related bill CRS 2015-10-21 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-10-21 Introduced in Senate IntroReferral 10000 9 Library of Congress G000562 Sen. Gardner, Cory [R-CO] Cory Gardner R CO N D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2015-10-21 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Health 00 2015-10-21 Introduced in Senate 2015-10-28T18:58:21Z Rare Disease Innovation Act

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.

Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.

The FDA must report every five years on the effect of this expansion of the humanitarian device exception.

]]> Rare Disease Innovation Act Display Title Rare Disease Innovation Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption. Introduced in Senate IS Short Titles as Introduced Rare Disease Innovation Act Introduced in Senate 2015-10-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2188is/xml/BILLS-114s2188is.xml 2015-10-21 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.