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.

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 8 February 2012

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• Introduced in House (PDF)

  Introduced in House · EN · 8 February 2012

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• Introduced in House

  summary · EN · 8 February 2012

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