Industry Proposes TCET Timeline, CED Changes During CMS Stakeholder Call

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.