US FDA invites feedback on IOM advice to scrap 510(k) process
This article was originally published in RAJ Devices
The US Food and Drug Administration is inviting feedback from the public on a controversial report by Institute of Medicine that is calling on the agency to abandon its pre-market notification process for clearing most medium- and low-risk medical devices in favour of an entirely new framework1,2.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.
The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these.