Special Controls Set By FDA For External Pacers, Analyzers
This article was originally published in The Gray Sheet
Executive Summary
A final order from the agency places external pacemaker pulse generators in class II, and also puts pacing system analyzers into a separate class II category – including triple-chamber analyzers, which was previously been regulated as class III PMA devices. All new language or significantly modified products in the categories will be subject to 510(k)s.
You may also be interested in...
US FDA Electromagnetic Compatibility Guidance Finalized
In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.
Moderna Files COVID-19 Vaccine After Second Impressive Read-Out
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.
Sanofi's Dupixent Cleared For Children With Atopic Dermatitis In EU
The French major and Regeneron have racked up another indication for Dupixent with the blockbuster getting approval in Europe to treat children with severe eczema.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: