H.R.3207 - Modernizing Laboratory Test Standards for Patients Act of 2011

To amend the Public Health Service Act to create a pathway for premarket notification and review of laboratory-developed tests, and for other purposes. view all titles (2)

All Bill Titles

  • Official: To amend the Public Health Service Act to create a pathway for premarket notification and review of laboratory-developed tests, and for other purposes. as introduced.
  • Short: Modernizing Laboratory Test Standards for Patients Act of 2011 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
10/14/11
 
 
 
 
 
 
 

Official Summary

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,

Official Summary

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).

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