As the FDA revamps the medical device approval process, significant overhauls are expected for both the PMA and 510(k) pathways. Medtech Insight is presenting a series of articles focusing on the effect these changes will have to the industry, starting with this first installment focused on potential changes to premarket approvals.

With many non-CE marked products being allowed onto various EU member state markets, who is going to monitor compliance? TÜV-SÜD’s Bassil Akra calls for cooperation to avoid unsafe products being used on patients.

Indian drug makers appear confident of meeting both domestic and global requirements for hydroxychloroquine sulphate after India relaxed export curbs on the product, subject to strict monitoring, against the backdrop of requests from global heads of government for supplies of the potential treatment for COVID-19.