S 4098 · 109th Congress · Health

Pediatric Medical Device Safety and Improvement Act of 2006

Introduced 2006-12-06· Sponsored by Sen. Dodd, Christopher J. [D-CT]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11346-11348)(2006-12-06)

Plain Language Summary

[AI summary unavailable — showing source text] Pediatric Medical Device Safety and Improvement Act of 2006 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators and physicians access funding for pediatric medical device development. Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development. Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Allows…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (2)

1 Democrat1 Republican