510(k) ball back in FDA’s court – agency must not fault
This article was originally published in Clinica
More compelling claims emerged this month attesting to the need for the US FDA to be bold in its review of the 510(k) route of device regulatory approval.
You may also be interested in...
ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.
UK health minister Baroness Blackwood will introduce the new UK Medicines and Medical Devices Bill before Parliament today, just before the House of Commons goes into recess. The government wants new legislation for devices and medicines in place before the end of the Brexit transition period.
EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.