Standards published for live case demonstrations involving medical devices
This article was originally published in RAJ Devices
Six cardiovascular societies from around the globe have issued a statement outlining the first-of-their-kind standards that medtech companies and institutions should consider while performing and broadcasting live case demonstrations at medical conferences1,2. The statement appears in the October issue of HeartRhythm Journal and is accompanied by a companion article authored by the US Food and Drug Administration that explains the agency's role in the regulation of live demonstrations involving the use of investigational devices on patients enrolled in clinical studies3.
You may also be interested in...
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.
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.