Health Care Financing Administration Incoming Chief Scully will meet with HHS Secretary Thompson by May 31 to discuss agency restructuring and a name change. Scully tells Senate Finance committee he plans to expedite agency's payment processes and improve seniors' access to new medical technologies. China Medical Device Regulators might participate in multilateral a quality systems regulation training program tentatively slated for late summer, Commerce Department officials say. Medical subgroup of U.S. Joint Commission on Commerce and Trade meets with Chinese, Korean and Taiwanese regulators to survey regulatory, reimbursement policies. U.S. Deptartment of Commerce update on China device regulations.
Action is necessary to avert further development of separate policies by member states.
Final European Commission decision is expected in June. Applications With Clinical Data is acceptable to device center director Feigal, he indicates at Medical Device Manufacturers Association annual meeting May 18. Although change would require legislation, and Congress is not due to review the program until 2006, Feigal suggests the change could come earlier. Device Center Least Burdensome Guidance Implementation will be eased by favorable comments from device industry and by swift finalization, Office of Device Evaluation and industry representatives say at Medical Device Manufacturers Association annual meeting May 17. FDA officials recount internal debates over in vitro diagnostics.