http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_HR_1494.html?rev=5086 <p>H.R. 1494 would improve the process for the development of needed pediatric medical devices.</p> <h2 id="toc0"> Detailed Summary </h2> <p>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.</p> <p>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.</p> <p>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.</p> <p>Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development.</p> <p>Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices.</p> <p>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.</p> <p>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.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc1"> Status of the Legislation </h2> <p>Latest Major Action: 3/13/2007: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc2"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc3"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 5086@http://www.washingtonwatch.com Sat, 21 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_1494.html?rev=5087 <p>H.R. 1494 would improve the process for the development of needed pediatric medical devices.</p> <h2 id="toc4"> Detailed Summary </h2> <p>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.</p> <p>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.</p> <p>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.</p> <p>Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development.</p> <p>Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices.</p> <p>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.</p> <p>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.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc5"> Status of the Legislation </h2> <p>Latest Major Action: 3/14/2007: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc6"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc7"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 5087@http://www.washingtonwatch.com Sat, 21 Jul 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_1494.html 3/14/2007: Referred to House subcommittee. Status: Referred to the Subcommittee on Health. 23919@http://www.washingtonwatch.com Wed, 14 Mar 2007 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_1494.html 3/13/2007: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce. 19085@http://www.washingtonwatch.com Tue, 13 Mar 2007 00:00:00 EDT