MEDICAL DEVICE MANUFACTURERS ASSOCIATION

Issues relating to the STRONGER Patents Act and Section 101 reform

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 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

Issues related to Medicare coverage reform Issues related to the coverage for FDA Breakthrough products and the H.R. 5343 and S.1717 Ensuring Patient Access to Critical Breakthrough Products Act TCET Issues related to the New Technology Add on Payment (NTAP) Issues related to coverage of telehealth services Issues related to physician fee schedule Issues related to CMS expansion of prior authorization requirements for medical procedures Issues related to reimbursement of artificial intelligence in healthcare

Issues related to R&D tax credit, bonus depreciation, and interest deductability

Issues related to global trade and tariffs Issues related to United States-Mexico-Canada Agreement (USMCA)

Issues related to appropriations and user fee funding for the Food and Drug Administration

Issues related to the reauthorization of the Small Business Innovation Research (SBIR) Program