3.0.0 830 2023-01-11T19:46:20Z 2023-01-11T19:46:20Z Senate S S 2007-03-08 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-03-09T00:45:43Z Pediatric Medical Device Safety and Improvement Act of 2007 110 1494 HR 2007-03-14 Referred to the Subcommittee on Health. Related bill CRS 2007-03-08 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2921-2923) IntroReferral 2007-03-08 Sponsor introductory remarks on measure. (CR S2920-2921) IntroReferral B00100 9 Library of Congress 2007-03-08 Introduced in Senate IntroReferral 10000 9 Library of Congress D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN N C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2007-03-21 False Health Biomedical engineering Business records Child health Commerce Congress Congressional investigations Congressional reporting requirements Data banks Department of Health and Human Services Economics and Public Finance Electronic data interchange Families Federal advisory bodies Food and Drug Administration (FDA) Government Operations and Politics Government paperwork Government publicity Grants-in-aid Health information systems Health surveys Medical research Medical supplies Nonprofit organizations Product development Product safety Science, Technology, Communications Social Welfare Standards Health 00 2007-03-08 Introduced in Senate 2007-05-04T17:16:11Z 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.

]]> Pediatric Medical Device Safety and Improvement Act of 2007 Official Title as Introduced A bill to improve the process for the development of needed pediatric medical devices. Introduced in Senate IS Display Title Pediatric Medical Device Safety and Improvement Act of 2007 Short Titles as Introduced Pediatric Medical Device Safety and Improvement Act of 2007 Introduced in Senate 2007-03-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s830is/xml/BILLS-110s830is.xml 2007-03-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2921-2923) text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.