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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to establishing heart recovery as the standard of care, Support for H.R. Res 1301 Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
2024 · third_quarter · 3T
Issues related to establishing heart recovery as the standard of care, Support for H.R. Res 1301 Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to health equity and diversity in clinical trials Constituent issue follow-up
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2024 · second_quarter · Q2
Source: Senate LDA
Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Support for R&D expensing deduction for MedTech
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to establishing heart recovery as the standard of care, Support for H.R. Res 1301 Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to health equity and diversity in clinical trials Constituent issue follow-up
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to the implementation of the FDA Medical Device User Fee Agreement Issues related to heart recovery Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization Issues related to medical device supply chain and sterilization Issues related to healthcare work force development
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to the implementation of the FDA Medical Device User Fee Agreement Issues related to heart recovery Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization Issues related to medical device supply chain and sterilization Issues related to healthcare work force development
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
Ensuring Patient Access to Critical Breakthrough Products Act of 2024
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to IPPS rule making and changes related to external heart assist Issues related to medical device supply chain and sterilization Issues related to healthcare work force development Issues related to health equity and diversity in clinical trials FDA approval pathways for medical technologies Cardiovascular health
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
Health Care Prices Revealed and Information to Consumers Explained Transparency Act
Client: ABIOMED, INC · Firm: ABIOMED, INC
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. H.R. 4617, Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to Ensuring Access to Critical Breakthrough Products Act Issues related to access and CMS reimbursement for heart assist devices.
To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on the medical device excise tax.
Client: ABIOMED, INC · Firm: ABIOMED, INC
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. H.R. 4617, Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to Ensuring Access to Critical Breakthrough Products Act Issues related to access and CMS reimbursement for heart assist devices.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. H.R. 4617, Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.
Client: ABIOMED, INC · Firm: ABIOMED, INC
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Support for repeal of the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Advancing Breakthrough Devices for Patients Act to promote innovation and regulatory efficiency. (Legislation not yet introduced). H.R. 1736, Legislation to improve processes for inspections of medical device establishments.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to the implementation of the 21st Century Cures Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Support for repeal of the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Advancing Breakthrough Devices for Patients Act to promote innovation and regulatory efficiency. (Legislation not yet introduced). H.R. 1736, Legislation to improve processes for inspections of medical device establishments.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to the implementation of the 21st Century Cures Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Support for repeal of the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Advancing Breakthrough Devices for Patients Act to promote innovation and regulatory efficiency. (Legislation not yet introduced). H.R. 1736, Legislation to improve processes for inspections of medical device establishments.
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.
Advancing Breakthrough Devices for Patients Act of 2016
Client: ABIOMED, INC · Firm: ABIOMED, INC
- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.
- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.
Issues related to establishing heart recovery as the standard of care, Support for H.R. Res 1301 Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2024 · first_quarter · Q1
Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Support for R&D expensing deduction for MedTech
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · fourth_quarter · Q4
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to medical device supply chain and sterilization Issues related to health equity and diversity in clinical trials Issues related to healthcare cost transparency, HR 5378 and S 3548 Issues related to CMS coverage determinations, HR 5389 and HR 5392
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · third_quarter · Q3
Issues related to the implementation of the FDA Medical Device User Fee Agreement (MDUFA) Issues related to establishing heart recovery as the standard of care Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to IPPS rule making and changes related to external heart assist Issues related to medical device supply chain and sterilization Issues related to healthcare work force development Issues related to health equity and diversity in clinical trials FDA approval pathways for medical technologies Cardiovascular health
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · second_quarter · Q2
Issues related to the implementation of the FDA Medical Device User Fee Agreement Issues related to heart recovery Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization Issues related to medical device supply chain and sterilization Issues related to healthcare work force development
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · first_quarter · Q1
Issues related to the implementation of the FDA Medical Device User Fee Agreement Issues related to heart recovery Education on CMS coverage for breakthrough technologies, HR 1691 Issues related to the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization Issues related to medical device supply chain and sterilization Issues related to healthcare work force development
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Q4
- Issues relating to FDA medical device user fee reauthorization legislation (MDUFA) and the use of real world data - Education on heart recovery as the standard of care and increased diversity CV clinical trials - Issues relating to the supply chain for medical products - Issues related to Medicare coverage reform - Issues related to Health Equity
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Q3
- Issues relating to FDA user fee reauthorization and the use of real world data - Support heart recovery as the standard of care and increased diversity CV clinical trials - Issues relating to the supply chain for medical products - Education on FDA breakthrough medical device issues and use of RWE
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Q2
- Issues relating to FDA user fee reauthorization and the use of real world data - Support heart recovery as the standard of care and increased diversity CV clinical trials - Issues relating to the supply chain for medical products - Education on FDA breakthrough medical device issues and use of RWE
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Q1
- Issues relating to the reauthorization of MDUFA V - Education on the heart muscle recovery and support for continued diversity CV clinical trials - Issues relating to the supply chain for medical products - Education on FDA breakthrough medical device issues and use of RWE
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · fourth_quarter · Q4
- Issues relating to the reauthorization of the Medical Device User Fee and Modernization Act - Issues relating to heart recovery - Issues relating to the supply chain for medical products - Education on FDA Breakthrough Medical Device Issues and use of RWE
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · third_quarter · Q3
- Issues relating to the reauthorization of the Medical Device User Fee and Modernization Act - Issues relating to heart recovery - Issues relating to the supply chain for medical products - Issues relating to R&D for medical devices and supporting competitive tax policies - Education on FDA Breakthrough Medical Device Issues
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · second_quarter · Q2
- Issues relating to the reauthorization of the Medical Device User Fee and Modernization Act - Issues relating to heart recovery - Issues relating to the supply chain for medical products - Issues relating to R&D for medical devices and supporting competitive tax policies - Education on FDA Breakthrough Medical Device Issues
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2021 · first_quarter · Q1
- Issues relating to the Medical Device User Fee and Modernization Act - Issues relating to the supply chain for medical products - Education on FDA Breakthrough Medical Device Issues
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Q4
Issues related to promoting innovation in the med-tech industry. Issues related to education on the new field of heart recovery. Issues related to EUA authorizations for COVID-19.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Q3
Issues related to promoting innovation in the med-tech industry. Issues related to education on the new field of heart recovery. Issues related to EUA authorizations for COVID-19.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Q2
Issues related to promoting innovation in the med-tech industry. Issues related to Medicare coverage reform. Issues related to education on the new field of heart recovery. Issues related to coverage of telehealth services.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Q1
Issues related to promoting innovation in the med-tech industry and improving FDA regulatory processes. Issues related to Medicare coverage reform. Issues related to education on the new field of heart recovery.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · fourth_quarter · Q4
Issues related to promoting innovation in the med-tech industry and improving FDA regulatory processes. Issues related to Medicare coverage reform. Issues related to education on the new field of heart recovery.
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Q3
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
Issues related to promoting innovation in the med-tech industry and improving FDA regulatory processes. Issues related to Medicare coverage reform. Issues related to education on the new field of heart recovery.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Q2
Issues related to promoting innovation in the med-tech industry and improving FDA regulatory processes. Issues related to Medicare coverage reform. Issues related to education on the new field of heart recovery.
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Q1
H.R. 2207, S. 692, and bills related to repeal of the medical device excise tax
Issues related to promoting innovation in the med-tech industry and improving FDA regulatory processes. Issues related to Medicare coverage reform.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Q4
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Q3
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to access for heart assist devices.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Q2
H.R. 184, S. 108 Medical Device Access and Innovation Protection Act. Bills related to the Medical Device Excise Tax. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery. Issues related to Ensuring Access to Critical Breakthrough Products Act Issues related to access and CMS reimbursement for heart assist devices.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Q1
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. H.R. 4617, Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Q4
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to the implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to the implementation of the 21st Century Cures Act. Issues related to improved awareness of cardiovascular disease and the new field of heart recovery.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Q3
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Q2
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Legislation related to the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Issues related to Ensuring Access to Critical Breakthrough Products Act. Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act. Issues related to implementation of the 21st Century Cures Act. Issues related to postmarket regulation of medical devices. Issues related to awareness of cardiovascular disease and the new field of heart recovery.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Q1
S. 108, H.R. 184, Medical Device Access and Innovation Protection Act. Support for repeal of the medical device excise tax. Issues relating to the Medical Device User Fee Agreement with respect to promoting innovation in the medical technology industry. Advancing Breakthrough Devices for Patients Act to promote innovation and regulatory efficiency. (Legislation not yet introduced). H.R. 1736, Legislation to improve processes for inspections of medical device establishments.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Q4
- Issues related to promoting competitiveness of the medical technology industry and the impact of federal policies. - H.R. 160, (Protect Medical Innovation Act), S. 149 (Medical Device Access and Innovation Protection Act)and provisions related to repeal of the medical device excise tax. - S.1077 Advancing Breakthrough Devices for Patients Act of 2015, provisions relating to breakthrough pathway.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · RR
Support of medical device tax repeal and innovation related provisions of the 21st century cures legislation.