All Medical technology Legislation - Federal Government
S.3409 - A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.
Latest Action: 07/31/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. Comment on Bill S.3408 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes.
Latest Action: 07/31/2008 - Sponsor introductory remarks on measure. (CR S7960-7961) Bill Text A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes. 7/31/2008--Introduced. Comparative Effectiveness Research Act of 2008 - Amends title XI (General Provisions, Peer Review, and Administrative Simplification) of the Social Security Act to provide for a program of comparative effectiveness research for health care. Defines "comparative effectiveness research" as research evaluating and comparing the implications and outcomes of two or more health care strategies to address a particular medical condition. Establishes the Health Care Comparative Effectiveness Research Institute as a nonprofit, nongovernmental, corporation to conduct research on the effectiveness of health care treatments, including pharmaceuticals, medical devices and procedures, and other therapies.[...] show full description S.3398 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Latest Action: 07/31/2008 - Sponsor introductory remarks on measure. (CR S7953-7954) Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. 7/31/2008--Introduced.
Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act. H.R.6381 - To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.
Latest Action: 06/26/2008 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. 6/26/2008--Introduced.
Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act. H.R.6270 - To amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes.
Latest Action: 06/17/2008 - Referred to the Subcommittee on Health. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 6/12/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device [...] show full description H.R.6241 - To amend title XVIII of the Social Security Act to include vision restoration therapy devices and associated software used in the patient's home to treat impaired visual function due to acquired brain injury within the definition of durable medical equipment under the Medicare Program.
Latest Action: 06/13/2008 - Referred to the Subcommittee on Health. Bill Text To amend title XVIII of the Social Security Act to include vision restoration therapy devices and associated software used in the patient's home to treat impaired visual function due to acquired brain injury within the definition of durable medical equipment under the Medicare Program. 6/11/2008--Introduced.
Restorative and Enhanced Vision Access for Medicare Patients (REVAMP) Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act to cover vision restoration therapy devices and associated software used in the patient's home to treat impaired visual function as durable medical equipment (DME). Latest Action: 05/22/2008 - Read twice and referred to the Committee on Finance. Bill Text A bill to provide for comprehensive health reform. 5/22/2008--Introduced. Making Health Care More Affordable Act of 2008 - Amends the Internal Revenue Code (IRC) to allow individual taxpayers a refundable tax credit for health insurance costs paid.Amends the Employee Retirement Income Security Act of 1974 (ERISA) to provide for establishment and governance of association health plans (AHPs), which are group health plans whose sponsors are trade, industry, professional, chamber of commerce, or similar business associations and which meet certain ERISA certification requirements. Amends the Public Health Service Act to provide that the laws of the state designated by a health insurance issuer (primary state) shall apply to individual health insurance coverage offered by that issuer in the primary state and in any other state (secondary state), but only if the coverage and issuer comply with certain requirements.Promoting Health for Future Generations Act [...] show full description S.3046 - A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes.
Latest Action: 05/21/2008 - Sponsor introductory remarks on measure. (CR S4625) Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 5/21/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or [...] show full description S.3020 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices.
Latest Action: 05/15/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices. 5/15/2008--Introduced. Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act. Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty. Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial [...] show full description S.2989 - A bill to direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes.
Latest Action: 05/07/2008 - Sponsor introductory remarks on measure. (CR S3899-3900) Bill Text A bill to direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes. 5/7/2008--Introduced. National Neurotechnology Initiative Act - Defines "neurotechnology" to mean the science and technology that allows an individual to analyze, understand, treat, and heal the brain and nervous system.Requires the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, under which the Secretary shall: (1) establish goals, priorities, and metrics for evaluation for federal neurotechnology research, development, and commercialization; (2) increase the investment in federal research, development, and translational programs in neurotechnology to achieve such goals; and (3) increase interagency coordination.Requires the Secretary to establish the National Neurotechnology Coordination Office and the National Neurotechnology Advisory Council.Requires the Director [...] show full description H.R.5989 - To direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes.
Latest Action: 05/08/2008 - Referred to the Subcommittee on Health. Bill Text To direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes. 5/7/2008--Introduced. National Neurotechnology Initiative Act - Defines "neurotechnology" to mean the science and technology that allows an individual to analyze, understand, treat, and heal the brain and nervous system.Requires the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, under which the Secretary shall: (1) establish goals, priorities, and metrics for evaluation for federal neurotechnology research, development, and commercialization; (2) increase the investment in federal research, development, and translational programs in neurotechnology to achieve such goals; and (3) increase interagency coordination.Requires the Secretary to establish the National Neurotechnology Coordination Office and the National Neurotechnology Advisory Council.Requires the Director of the [...] show full description Latest Action: 05/19/2008 - Referred to the Subcommittee on Health. Bill Text To provide for comprehensive health reform. 5/1/2008--Introduced. Making Health Care More Affordable Act of 2008 - Amends the Internal Revenue Code (IRC) to allow individual taxpayers a refundable tax credit for health insurance costs paid.Amends the Employee Retirement Income Security Act of 1974 (ERISA) to provide for establishment and governance of association health plans (AHPs), which are group health plans whose sponsors are trade, industry, professional, chamber of commerce, or similar business associations and which meet certain ERISA certification requirements. Amends the Public Health Service Act to provide that the laws of the state designated by a health insurance issuer (primary state) shall apply to individual health insurance coverage offered by that issuer in the primary state and in any other state (secondary state), but only if the coverage and issuer comply with certain requirements.Promoting Health for Future Generations Act of 2008 [...] show full description S.2931 - A bill to amend title XVIII of the Social Security Act to exempt complex rehabilitation products and assistive technology products from the Medicare competitive acquisition program.
Latest Action: 04/29/2008 - Sponsor introductory remarks on measure. (CR S3510) Bill Text A bill to amend title XVIII of the Social Security Act to exempt complex rehabilitation products and assistive technology products from the Medicare competitive acquisition program. 4/29/2008--Introduced.
Medicare Access to Complex Rehabilitative and Assistive Technology Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act to exempt complex rehabilitation products and assistive technology products from the Medicare competititve acquisition program. H.R.4321 - To amend the Public Health Service Act to authorize medical simulation enhancement programs, and for other purposes.
Latest Action: 12/06/2007 - Referred to the Subcommittee on Health. Bill Text To amend the Public Health Service Act to authorize medical simulation enhancement programs, and for other purposes. 12/6/2007--Introduced. Enhancing Safety in Medicine Utilizing Leading Advanced Simulation Technologies to Improve Outcomes Now Act of 2007 - Amends the Public Health Service Act to require the Director of the Agency for Healthcare Research and Quality to conduct and support research, evaluations, initiatives, and demonstration projects, and provide grants or enter into contracts or cooperative agreements, to enhance the deployment of medical simulation technologies and the incorporation of such technologies and equipment into medical, nursing, allied health, podiatric, osteopathic, and dental education and training protocols.Requires the Director to: (1) establish medical simulation centers of excellence; (2) promote innovation by conducting and supporting research on complex or challenging medical simulation and interdisciplinary simulation technologies [...] show full description H.R.3886 - To optimize the delivery of critical care medicine and expand the critical care workforce.
Latest Action: 04/25/2008 - Referred to the Subcommittee on Specialty Crops, Rural Development, and Foreign Agriculture. Bill Text To optimize the delivery of critical care medicine and expand the critical care workforce. 10/18/2007--Introduced. Patient-Focused Critical Care Enhancement Act - Requires the Secretary of Health and Human Services, acting through the Agency for Healthcare Research and Quality (AHRQ), to conduct research to assess: (1) the standardization of critical care protocols, intensive care unit layout, equipment interoperability, and medical informatics; and (2) the impact of differences in staffing, organization, size, and structure of intensive care units on access, quality, and efficiency of care. Requires the Secretary to undertake demonstration projects to: (1) optimize the provision of critical care services to Medicare beneficiaries through innovations in such areas as staffing and utilization of technology; and (2) measure and evaluate outcomes derived from a "family-centered" approach to the provision of inpatient critical care services that includes direct [...] show full description H.R.3825 - To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes.
Latest Action: 04/08/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-570. Bill Text To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes. 4/8/2008--Reported to House amended. (There is 1 other summary) Newborn Screening Saves Lives Act of 2008 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to award grants to eligible entities to: (1) provide screening, counseling, or health care services to newborns and children having or at risk for heritable disorders; (2) provide education and training in newborn screening and congenital, genetic, and metabolic disorders to health care professionals and newborn screening laboratory personnel; (3) develop and deliver educational [...] show full description H.R.3673 - To require the Secretary of Defense to establish a National Trauma Institute.
Latest Action: 10/19/2007 - Referred to the Subcommittee on Military Personnel. Bill Text To require the Secretary of Defense to establish a National Trauma Institute. 9/26/2007--Introduced.
National Trauma Institute Act - Directs the Secretary of Defense to establish a National Trauma Institute in San Antonio, Texas. States that the Institute shall: (1) develop medical technologies to improve injury prevention and diagnosis, survival, and quality of life for victims of trauma and burn injury; and (2) implement a multidisciplinary, multi-center collaborative research effort, including coordination of trauma research carried out at Wilford Hall Medical Center, San Antonio, Texas, University Hospital, the University of Texas Health Science Center, San Antonio, Texas, and Brooke Army Medical Center, San Antonio, Texas. H.R.3235 - To ensure the development and responsible stewardship of nanotechnology.
Latest Action: 08/24/2007 - Referred to the Subcommittee on Research and Science Education. Bill Text To ensure the development and responsible stewardship of nanotechnology. 7/31/2007--Introduced. Nanotechnology Advancement and New Opportunities Act - Directs the Secretary of Commerce, if $100 million is made available from the private sector for the establishing a Nanomanufacturing Investment Partnership, to establish such a Partnership to provide funding for precommercial nanomanufacturing research and development projects. Allows the Partnership to provide funding through direct investments in specified mechanisms designed to advance nanomanufacturing. Requires return on investment of amounts resulting from the commercialization of developed technologies to the Partnership. Requires establishment of an advisory board to assist the Secretary in carrying out the Partnership. Amends the Internal Revenue Code of 1986 (IRC) to allow a tax credit for the purchase of qualified nanotechnology developer stock. Authorizes establishment within the Technology [...] show full description S.1858 - A bill to amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes.
Latest Action: 04/24/2008 - Signed by President. Bill Text A bill to amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes. 4/24/2008--Public Law. (There are 3 other summaries) (This measure has not been amended since it was passed by the Senate on December 13, 2007. The summary of that version is repeated here.)Newborn Screening Saves Lives Act of 2007 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to award grants to eligible entities to: (1) provide screening, counseling, or health care services to newborns and children having or at risk for heritable disorders; (2) provide education and training in newborn screening and [...] show full description H.R.2889 - To amend the Public Health Service Act to improve newborn screening activities, and for other purposes.
Latest Action: 06/27/2007 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Public Health Service Act to improve newborn screening activities, and for other purposes. 6/27/2007--Introduced. Screening for Health of Infants and Newborns Act or the SHINE Act - Amends the Public Health Service Act to require the Director of the Centers for Disease Control and Prevention (CDC) to develop guidelines that states may follow in reporting data from newborn screening tests. Requires the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to develop guidelines to: (1) monitor and evaluate newborn screening activities; and (2) coordinate the results of surveillance activities. Requires the Secretary, acting through the Director of CDC and the National Center on Birth Defects and Developmental Disabilities, to develop a surveillance system for newborn screening. Directs the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns [...] show full description H.R.2892 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, chapter 89 of title 5, United States Code, and title 10, United States Code, to require coverage for the treatment of infertility.
Latest Action: 09/11/2007 - Referred to the Subcommittee on Health, Employment, Labor, and Pensions. Bill Text To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, chapter 89 of title 5, United States Code, and title 10, United States Code, to require coverage for the treatment of infertility. 6/27/2007--Introduced. Family Building Act of 2007 - Amends the Public Health Service Act and the Employee Retirement Income Security Act (ERISA) to require a group health plan that provides coverage for obstetrical services to include coverage for non-experimental treatment of infertility that is deemed appropriate by a participant or beneficiary and the treating physician. Requires coverage for assisted reproductive technology only if certain conditions are met. Prohibits a group health plan from taking specified actions to avoid the requirements of this Act.Applies such requirements to health insurance coverage offered in the individual market and coverage offered through Federal Employees Health Benefit (FEHB) plans and Department of Defense [...] show full description S.1712 - A bill to amend the Public Health Service Act to improve newborn screening activities, and for other purposes.
Latest Action: 06/27/2007 - Sponsor introductory remarks on measure. (CR S8615-8616) Bill Text A bill to amend the Public Health Service Act to improve newborn screening activities, and for other purposes. 6/27/2007--Introduced. Screening for Health of Infants and Newborns Act or the SHINE Act - Amends the Public Health Service Act to require the Director of the Centers for Disease Control and Prevention (CDC) to develop guidelines that states may follow in reporting data from newborn screening tests. Requires the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to develop guidelines to: (1) monitor and evaluate newborn screening activities; and (2) coordinate the results of surveillance activities. Requires the Secretary, acting through the Director of CDC and the National Center on Birth Defects and Developmental Disabilities, to develop a surveillance system for newborn screening. Directs the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns [...] show full description S.1687 - A bill to provide for global pathogen surveillance and response.
Latest Action: 09/11/2007 - Committee on Foreign Relations. Reported by Senator Biden without amendment. With written report No. 110-152. Bill Text A bill to provide for global pathogen surveillance and response. 9/11/2007--Reported to Senate without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Global Pathogen Surveillance Act of 2007 - (Sec. 4) Prohibits assistance under this Act to an eligible developing country that does not: (1) permit World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDCP) personnel to investigate infectious disease outbreaks within its borders; and (2) provide pathogen surveillance data to appropriate U.S. and international agencies and organizations. Authorizes the Secretary of State (Secretary) to waive such prohibition if in the U.S. national interest. (Sec. 5) Prohibits any participating foreign national from having unsupervised access to specified agents or toxins that may be used in [...] show full description S.1605 - A bill to amend title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program, and for other purposes.
Latest Action: 06/13/2007 - Sponsor introductory remarks on measure. (CR S7642-7643) Bill Text A bill to amend title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program, and for other purposes. 6/13/2007--Introduced. Craig Thomas Rural Hospital and Provider Equity Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act with respect to: (1) the Medicare disproportionate share hospital (DSH) adjustment for rural hospitals; (2) revision of the temporary increase in payments to certain rural hospitals (Medicare hold harmless provision); (3) the definition of low-volume hospital for purposes of the Medicare inpatient hospital payment adjustment; (4) Medicare wage index reclassifications for certain hospitals; (5) Medicare reasonable costs payments for certain clinical diagnostic laboratory tests furnished to hospitals in certain rural areas; (6) critical access hospitals; (7) the capital infrastructure revolving loan program; (8) the Medicare incentive [...] show full description H.R.2592 - To amend the Federal Food, Drug, and Cosmetic Act to provide for one or more Critical Path Public-Private Partnerships to implement the Critical Path Initiative of the Food and Drug Administration, and for other purposes.
Latest Action: 06/06/2007 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to provide for one or more Critical Path Public-Private Partnerships to implement the Critical Path Initiative of the Food and Drug Administration, and for other purposes. 6/6/2007--Introduced. Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any [...] show full description H.R.2560 - To amend the Federal Food, Drug, and Cosmetic Act to prohibit human cloning, and for other purposes.
Latest Action: 06/06/2007 - Ms. DeGette moved to suspend the rules and pass the bill. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to prohibit human cloning, and for other purposes. 6/5/2007--Introduced.
Human Cloning Prohibition Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make it unlawful for any person, including a governmental entity, to: (1) perform or attempt to perform human cloning; or (2) ship, mail, transport, or receive the product of human somatic cell nuclear transfer technology knowing that such product is for the purpose of human cloning. Sets forth criminal and civil penalties for violations of this Act. |
