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HR 3975 112th Congress House Health Administrative law and regulatory procedures Child health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health care coverage and access Health information and medical records Health programs administration and funding Health technology, devices, supplies

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.

Introduced: February 8, 2012 See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 10, 2012
Referred to the Subcommittee on Health.
Feb 8, 2012
Referred to the House Committee on Energy and Commerce.
Feb 8, 2012
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now February 10, 2012

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1