Listen to the podcast via the player below:
Device Week, 11 February 2021 – Stalled MDUFA V Negotiations Get Jump-Start
The US Food and Drug Administration and the medtech industry failed to come to terms on a user fee package by the January 15 deadline. But conversations have resumed, and some say we might see a final deal in the near future. Senior reporter Danny Al-Faruque has the scoop.
More from Regulation
• By
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
• By
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
• By
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
• By
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.
More from Policy & Regulation
• By
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
• By
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
• By
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.