The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.
FDA has delayed implementation of proposed changes to its definition of “intended use” by one year in the face of significant stakeholder protest.
A final rule published Jan. 9 would have broadened the definition of “intended use” to what is called the “totality...
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
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.
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.
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.
