S. 4098: Pediatric Medical Device Safety and Improvement Act of 2006

109th Congress · introduced 2006-12-06 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11346-11348)

federal

Follow this bill, step by step

Where it came from: introduced 2006-12-06 · official record
Who proposed it: Sen. Dodd, Christopher J. [D-CT] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S11346-11348) Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Pediatric Medical Device Safety and Improvement Act of 2006

Plain summary

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 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. Requires the Secretary to adopt voluntary national standards for medical device coding.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

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What does this mean? (plain words)

Official text

Pediatric Medical Device Safety and Improvement Act of 2006

Source: Congressional Research Service summary (Introduced in Senate)

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Officials and money

Sponsor: Sen. Dodd, Christopher J. [D-CT] · 2 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Exemption: A rule that removes certain people, property or activities from a tax or requirement.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-109s4098.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/109/s>

Record fed-us-cong109-s4098 · catalog fed-us-congress-bills-cong109 · updated 2026-11-15 by psicol fed-bills-cong109