Several bills that try to lift barriers to development and use of device alternatives for pain management in response to the opioid crisis were recently approved by the US House.
[Editor's note: Check out Medtech Insight's US Congress Tracker for a comprehensive look at the detail and status of all medtech-related legislation that has been introduced during the current congressional session.]
More than two dozen pieces of opioid-crisis related legislation have been approved by the US House in the first half...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
