COVID-19: FDA Schedules 4 More Virtual Town Halls Through October
The US agency has announced another month of webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the novel coronavirus.
You may also be interested in...
US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More
Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.
It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.