Newsletter - March 25, 2021
More Regulation is Better for Certain Medical Devices: Industry Tells FDA
In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA announced 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 expose....Read More
FDA’s Tango with the EUAs Exposed an Agency Disconnected from the Real World
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...Read More
More Regulation is Better for Certain Medical Devices: Industry Tells FDA
In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA announced 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 expose....Read More
FDA’s Tango with the EUAs Exposed an Agency Disconnected from the Real World
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...Read More
