EPA Regulation of Ethylene Oxide NESHAP Rule and FIFRA Interim Decision Re-Registration PFAS issues: Fluoro Polymers [Per- and polyfluoroalkyl (PFAS) type(s) of substances used in medical devices]
Workforce Development
Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (legislation pending); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT) Unique Device Identifier (UDI) in Medicare claims form FDA Reform: Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) FDA Modernization: modeling non-animal studies for medical device studies; Medical Device Electronic Labeling Act (H.R. 1539) Biotechnology: reduce regulatory barriers; align public-private investment Nursing Workforce Shortage
TCJA Provisions: corporate tax rate; incentives to promote U.S. manufacturing; research and development amortization; bonus depreciation; construction of workforce housing; new market tax credit (H.R. 1103)
Beneficial Owner
USDA Sec. 502 low-income, rural areas in need of affordable housing proposals for workforce development