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Legislative Progress
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vs 3,548 other S bills in the 114th — cohort avg 43d
Rare Disease Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices. The FDA must report every five years on the effect of this expansion of the humanitarian device exception.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (2)
2016 · fourth_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries Issues related to the regulation and publication of clinical trials for medical devices Issues related to FDA public communications regarding emerging signals Issues related to the regulation of blood glucose meters HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to FDA inspection of foreign and domestic manufacturing facilities Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act
Client expense: $700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act
Client expense: $680,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to the regulation of contact lenses S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act
Client expense: $1,140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
H.R. 6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 209/S. 139 - Ensuring Access to Clinical Trials Act S. 2188 - Rare Disease Innovation Act H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act H.R. 2624 - Part D Beneficiaries Appeals Fairness Act S. 1421 - OPEN Act
Client expense: Not reported · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Social Security Administration (SSA)
2015 · fourth_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act
Client expense: $980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act
Client expense: $910,000 · Firm income: Not reported
2015 · third_quarter · Health Issues
H.R. 6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 209/S. 139 - Ensuring Access to Clinical Trials Act S. 2188 - Rare Disease Innovation Act H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act H.R. 2624 - Part D Beneficiaries Appeals Fairness Act S. 1421 - OPEN Act
Client expense: Not reported · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Social Security Administration (SSA)
Government targets: HOUSE OF REPRESENTATIVES, SENATE