S.1700 - Medical Device Regulatory Improvement Act

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to device review determinations and conflicts of interest, and for other purposes. view all titles (2)

All Bill Titles

  • Official: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to device review determinations and conflicts of interest, and for other purposes. as introduced.
  • Short: Medical Device Regulatory Improvement Act as introduced.

This Bill currently has no wiki content. If you would like to create a wiki entry for this bill, please Login, and then select the wiki tab to create it.

Bill’s Views

  • Today: 1
  • Past Seven Days: 1
  • All-Time: 1,575
 
Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
10/13/11
 
 
 
 
 
 
 

Official Summary

Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irr

Official Summary

Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to:
(1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness;
(2) consider alternative approaches to evaluating device safety and effectiveness;
(3) use all reasonable mechanisms to lessen review times and render regulatory decisions;
(4) determine whether pre-clinical data can meet the statutory threshold for approval; and
(5) utilize, whenever practicable, alternatives to randomized, controlled clinical trials if clinical data are needed. Requires the Secretary, in determining the least burdensome means of determining substantial equivalence, to:
(1) focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device,
(2) not request or accept information unrelated or irrelevant to the substantial equivalence evaluation,
(3) review the labeling of the device to assess the intended use of the device and not evaluate issues that do not present a major impact on the intended use as set forth in the labeling,
(4) consider alternative approaches to evaluating substantial equivalence, and
(5) use all reasonable mechanisms to lessen review times and render regulatory decisions. Repeals conflict-of-interest provisions that are specific to the Food and Drug Administration (FDA) and provides for the continued applicability of conflict-of-interest provisions otherwise applicable to advisory committees, federal employees, and special government employees. Requires the Secretary to contract with an eligible entity for a review of the management and regulatory processes at the Center for Devices and Radiological Health.

...Read the Rest

Organizations Supporting S.1700

  • Continuing Medical Education Coalition
  • California Healthcare Institute
  • Advanced Medical Technology Association
  • Boston Scientific

Organizations Opposing S.1700

  • Public Citizen
  • Project On Government Oversight




Vote on This Bill

100% Users Support Bill

1 in favor / 0 opposed
 

Send Your Senator a Letter

about this bill Support Oppose Tracking
Track with MyOC