US HB3005 | 2013-2014 | 113th Congress
Status
Spectrum: Slight Partisan Bill (Democrat 6-2)
Status: Introduced on August 2 2013 - 25% progression, died in committee
Action: 2013-08-02 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on August 2 2013 - 25% progression, died in committee
Action: 2013-08-02 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval. Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner inconsistent with such statement, or (2) engages in business communications regarding the product with an end user. Defines "business communications": (1) as oral, written, or electronic contact between a manufacturer or distributor of such a product and an end user regarding the product's functioning; and (2) includes any such contact consisting of technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.
Title
Medical Testing Availability Act of 2013
Sponsors
Rep. Michael Burgess [R-TX] | Rep. Julia Brownley [D-CA] | Rep. Anna Eshoo [D-CA] | Rep. Kay Granger [R-TX] |
Rep. Brian Higgins [D-NY] | Rep. Michael Honda [D-CA] | Rep. Scott Peters [D-CA] | Rep. Jackie Speier [D-CA] |
History
Date | Chamber | Action |
---|---|---|
2013-08-02 | House | Referred to the Subcommittee on Health. |
2013-08-02 | House | Referred to the House Committee on Energy and Commerce. |
Subjects
Consumer affairs
Drug safety, medical device, and laboratory regulation
Health
Health technology, devices, supplies
Medical research
Product safety and quality
Drug safety, medical device, and laboratory regulation
Health
Health technology, devices, supplies
Medical research
Product safety and quality
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/113th-congress/house-bill/3005/all-info |
Text | https://www.congress.gov/113/bills/hr3005/BILLS-113hr3005ih.pdf |