S.1622: FDA Device Accountability Act of 2016

About This Bill

  • This bill was introduced in the 114th Congress
  • This bill is primarily about health
  • Introduced June 18, 2015
  • Latest Major Action April 18, 2016

Bill Summary

FDA Device Accountability Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local. (Sec. 3) The Food and Drug Administration (FDA) must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver...

(Source: Library of Congress)

What Lawmakers Are Saying About This Bill

There are 5 statements associated with S.1622.

Congressional Budget Office Estimate

The Congressional Budget Office has produced a cost estimate for S.1622.

Bill Actions

Date Description
April 18, 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 426.
April 18, 2016
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Feb. 9, 2016
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
June 18, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
June 18, 2015

Introduced in the Senate by Richard M. Burr (R-N.C.)

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