Medical Device Recall Improvement Act

Issues related to MDUFA implementation; FDA staffing Issues relating to the medical product supply chain Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to HR 3723 - the Medical Device Electronic Labeling Act Issues related to PFAS and EtO Chemical regulation Issues related to the Valid Act of 2023 - H.R. 2369 Issues related to cyber security Issues related to consumer and health data privacy Issues related to regulation and reimbursement of artificial intelligence in healthcare Issues related to FDA's third party review program Issues related to HR 5662/S 2907 - the Medical Device Recall Improvement Act

Client expense: $300,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program Issues related to the President's Emergency Program for AIDS Relief (PEPFAR)

Client expense: $950,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program

Client expense: $1,042,000 · Firm income: Not reported

H.R. 8412 Clinical Trial Modernization Act S. 2907 Medical Device Recall Improvement Act Issues related to health care modernization and adoption of electronic health records. Issues related to cybersecurity of healthcare technology systems.

Client expense: $2,100,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology Issues related to FDAs third party review program

Client expense: $940,000 · Firm income: Not reported

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $960,000 · Firm income: Not reported

H.R. 8412 Clinical Trial Modernization Act S. 2907 Medical Device Recall Improvement Act Issues related to health care modernization and adoption of electronic health records. Issues related to cybersecurity of healthcare technology systems.

Client expense: $2,870,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 8412 Clinical Trial Modernization Act S. 2907 Medical Device Recall Improvement Act Issues related to health care modernization and adoption of electronic health records. Issues related to cybersecurity of healthcare technology systems.

Client expense: $2,070,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $880,000 · Firm income: Not reported

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Issues related to FDA device shortage reporting Issues related to FDA third-party review program Issues related to the transport of medical devices with batteries Issues related to artificial intelligence and other advanced software in health care H.R. 5662/S. 2907, the Medical Device Recall Improvement Act

Client expense: $850,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan Reimbursement and coverage of focused ultrasound technology HR 1328, the Medical Device Nonvisual Accessibility Act of 2023 Issues related to FDAs third party review program

Client expense: $1,030,000 · Firm income: Not reported

Issues related to disparities of care Issues related to medical device electronic labeling,including H.R. 3723 - Medical Device Electronic Labeling Act Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Issues related to FDA device shortage reporting Issues related to FDA third-party review program Issues related to the transport of medical devices with batteries Issues related to artificial intelligence and other advanced software in health care H.R. 5662/S. 2907, the Medical Device Recall Improvement Act

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Privacy Legislation Issues related to the medical supply chain Issues related to the competitiveness of the medtech industry and the impact of Federal Policies Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of diagnostic tests VALID Act of 2023 - H.R. 2369. Issues related to Health Equity Issues related to Public Health Emergency Preparedness (including Pandemic All Hazards Preparedness Act reauthorization) Issues related to the use of Artificial Intelligence Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation HR 3723 - the Medical Device Electronic Labeling Act HR 5662/S 2907 - the Medical Device Recall Improvement Act S 2672 - Improving Development and Distribution of Diagnostic Tests Act HR 3795 - Diagnostic Testing Preparedness Plan

Client expense: $680,000 · Firm income: Not reported

Tribal Sovereignty Truth and Healing Commission Act (H.R. 5444, S. 2907)

Client expense: Not reported · Firm income: $20,000

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), SENATE, Transportation, Dept of (DOT)