A short, seven-page draft guidance from the US agency lists submissions that must be sent to the FDA in an electronic format.
The US Food and Drug Administration released an easy-to-digest draft guidance on 25 September that lists the types of submissions that must be sent to the agency in an electronic format.
The FDA's short, seven-page "Providing Regulatory Submissions for Medical Devices in Electronic Format," dated 26 September, says these submission...
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
