Tag: medical devices
UK government confirms indefinite recognition of CE-marked medical devices
The UK government has confirmed that it will continue to accept CE-marked medical devices on a long-term basis, meaning devices and in-vitro diagnostic devices...
US FDA issues first draft guidance for AI-based medical device development
The US Food and Drug Administration (FDA) has issued draft guidance that includes recommendations to support development and marketing of safe and effective artificial...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
Seth J Worley
Seth J Worley (senior consultant, Cardiac Rhythm Device Management, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, Washington, DC, USA) considers that...