H.R. 3975 (112th): To amend title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act.

Feb 08, 2012 (112th Congress, 2011–2013)
Died (Referred to Committee)
Mike Rogers
Representative for Michigan's 8th congressional district
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Last Updated
Feb 08, 2012
2 pages

This bill was introduced on February 8, 2012, in a previous session of Congress, but was not enacted.

Introduced Feb 08, 2012
Referred to Committee Feb 08, 2012

No summaries available.

1 cosponsors (1D) (show)

House Energy and Commerce


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Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development.
Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development, fabrication, and distribution of the device where the request for such exemption is submitted on or before October 1, 2017 (currently, October 1, 2012).
Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) entitled "Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure" to take effect on January 1, 2013, unless such Commissioner issues the final rule before such date.

House Republican Conference Summary

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