The US House Energy and Commerce Health Subcommittee advanced a Republican-sponsored bill that would permit communications between manufacturers and private and public insurers about the benefits of unapproved devices and drugs. Democrats on the panel expressed strong reservations that FDA may feel unduly pressured by insurers to rush through product approvals.
[Editor's note: Follow progress with legislation impacting the device and diagnostics industry with Medtech Insight's US Congress Tracker.]
Proposed legislation that would permit device and drug companies to share economic or scientific information with private health insurers or the Centers for Medicare and Medicaid Services (CMS) was approved...
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
