WASHINGTON, DC - The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a legislative hearing for Tuesday, May 2, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining Improvements to the Regulation of Medical Technologies."
Earlier this month, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA).
As part of the effort to reauthorize these agreements, #SubHealth will consider additional bills consistent with efforts to support the review and regulation of medical devices.
“Medical devices play an important part in caring for and bettering the lives of patients with a variety of prognoses," said Chairman Burgess. “As we work toward advancing the FDA Reauthorization Act of 2017, it is important we consider some additional policies that will help patients and bolster this vital reauthorization."
The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. See Also
* Examining Improvements to the Regulation of Medical Technologies
