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H.R.3005 / 113th Congress

Medical Testing Availability Act of 2013

Referred to the Subcommittee on Health.

Official summary

Version 00 · Introduced in House · Aug 2, 2013

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.

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Who introduced it

Rep. Burgess, Michael C. [R-TX-26] · R–TX

Committees

  • Energy and Commerce Committee
7 cosponsorship records, including any withdrawals

Actions

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  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

  3. Introduced in House

  4. Introduced in House

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.

Source last updated: Aug 12, 2025. Consult Congress.gov for the current record.

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