US HB2443 | 2015-2016 | 114th Congress
Status
Spectrum: Partisan Bill (Republican 1-0)
Status: Introduced on May 19 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on May 19 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
Title
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Sponsors
Rep. Brett Guthrie [R-KY] |
History
Date | Chamber | Action |
---|---|---|
2015-05-22 | House | Referred to the Subcommittee on Health. |
2015-05-19 | House | Referred to the House Committee on Energy and Commerce. |
2015-05-19 | House | Introduced in House |
Same As/Similar To
HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects
Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/114th-congress/house-bill/2443/all-info |
Text | https://www.congress.gov/114/bills/hr2443/BILLS-114hr2443ih.pdf |