Day: March 25, 2021

Did the notification process, used as a precursor to filing an EUA for Covid diagnostic tests, help or hurt both the consumers and developers? A review of last years’ experience with the notification process for the EUA showed that FDA’s plan was poorly thought, knee-jerk reaction in the early days of the pandemic, and ended … Read more

In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA proposed that those devices are safe enough to not need such regulation and should be downgraded to 510k-exempt status. And in the process, the commenters exposed many holes in the current regulatory … Read more