H.R.3208 - Patients Come First Act of 2011

To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. view all titles (2)

All Bill Titles

  • Official: To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. as introduced.
  • Short: Patients Come First Act of 2011 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
10/14/11
 
 
 
 
 
 
 

Sponsor

Representative

John Shimkus

R-IL

View Co-Sponsors (17)

Official Summary

Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for

Official Summary

Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS):
(1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and
(2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to:
(1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices,
(2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner,
(3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and
(4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.

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