3.0.0 1494 2023-01-11T19:53:49Z 2023-01-11T19:53:49Z House H HR 2007-03-13 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2007-03-14T19:45:38Z Referred to 2007-03-13T14:32:30Z Pediatric Medical Device Safety and Improvement Act of 2007 110 830 S 2007-03-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2921-2923) Related bill CRS 2007-03-14 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2007-03-13 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-03-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-03-13 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2007-03-13 True R000033 Rep. Ramstad, Jim [R-MN-3] JIM RAMSTAD R MN 3 2007-04-17 False C001036 Rep. Capps, Lois [D-CA-23] LOIS CAPPS D CA 23 2007-04-17 False E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2007-04-17 False G000551 Rep. Grijalva, Raúl M. [D-AZ-7] Raúl Grijalva D AZ M. 7 2007-05-03 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 2007-03-13 Introduced in House 2007-05-04T17:28:32Z 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 To improve the process for the development of needed pediatric medical devices. Introduced in House IH 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 House 2007-03-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1494ih/xml/BILLS-110hr1494ih.xml 2007-03-14 Referred to the Subcommittee on Health. 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.