Regulatory & Reimbursement
Pathways Picks May 18: Dx Reforms in Senate; IVDR Prep in the EU, and More
In this week’s roundup: The US Senate unveils its draft FDA user fee bill, including comprehensive VALID Act reforms to regulation of diagnostics, while the House moves its user fee bill out of committee. EU regulatory updates including MedTech Europe preps for the IVD Regulations, more progress on standards recognition, and more MDR bottleneck data from notified bodies. Also, Google taps Bakul Patel, GAO looks at FDA COVID test efforts, and more global medtech policy updates.
