Skip to main content
HR 3207 112th Congress House Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Alternative dispute resolution, mediation, arbitration Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Licensing and registrations Marketing and advertising Medical tests and diagnostic methods User charges and fees

Modernizing Laboratory Test Standards for Patients Act of 2011

Introduced: October 14, 2011 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 14, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
 Plain-English summary Congressional Research Service

Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test.

Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses.

Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days.

Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health.

Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act.

Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).

What's happening now October 14, 2011

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2