3.0.0 1508 2023-01-11T13:49:03Z 2023-01-11T13:49:03Z Senate S 2021-04-29 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-04-29T19:42:17Z 2021-04-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-04-29 Introduced in Senate IntroReferral 10000 9 Library of Congress M001198 Sen. Marshall, Roger [R-KS] Roger Marshall R KS N S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2021-04-29 True C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2021-04-29 True Health Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies Licensing and registrations Health 00 2021-04-29 Introduced in Senate 2022-03-03T15:20:18Z This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product.

Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval.

Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

]]> A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes. Display Title A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes. Official Title as Introduced A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes. Introduced in Senate IS Introduced in Senate 2021-04-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s1508is/xml/BILLS-117s1508is.xml 2021-04-29 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.