S. 830 · 110th Congress
Pediatric Medical Device Safety and Improvement Act of 2007
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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DoddSponsor1 cosponsor · 1 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Pediatric Medical Device Safety and Improvement Act of 2007 - 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,…
What it does: CRS summary · Introduced in Senate · Mar 8, 2007
Pediatric Medical Device Safety and Improvement Act of 2007 - 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 the Secretary to require: (1) postmarket surveillance on certain devices that are expected to have significant use in pediatric populations; and (2) a prospective surveillance period of more than 36 months for such devices, as necessary.
Requires the Secretary, acting through the Commissioner of Food and Drugs, to establish a publicly accessible database of all studies and surveillance of medical devices.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Pediatric Medical Device Safety and Improvement Act of 2007
Latest action (Mar 8, 2007): Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2921-2923)
Policy area: Health · Origin: Senate · Introduced: Mar 8, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.